Antares vision and cognex enter a strategic agreement for joint developments in the pharmaceutical track&trace
Antares Vision, the European leader in Track & Trace applications for the pharmaceutical industry, today announces that it has entered a strategic partnership agreement with Cognex Europe for a joint development of inspection systems dedicated to track & trace and e-pedigree applications.
Under this agreement, Antares and Cognex technical teams will cooperate to develop and market new, high performance reading stations required to implement the next generation of Track&Trace systems.
The new developments will take advantage of the most advanced Cognex camera platforms – renewed to be at the leading edge in the artificial vision technology – to implement innovative reading tasks related to the aggregation phase of Track & Trace.
This means – for example - the ability to read several Datamatrix codes (over 100 simultaneously) even in difficult reading conditions such as in presence of fully wrapped bundles or in high speed applications.
The new solutions will be part of the ATS-Antares Tracking System, a complete suite of hardware and software to implement Traceability in accordance with the latest regulations in the pharmaceutical industry
ATS includes the widest range of serialization devices (over 7 different models) to print and check Datamatrix unique codes, and aggregation devices to build the parent-child relationship on board of packaging machines such as bundlers, case packers, palletizers.
The ATS software modules include a plant manager to interface corporate ERPs, manage unique serial numbers and communication to the Ministry of Health database, a line manager to monitor in real time the production line by line, and a warehouse module to manage commissioning and decommissioning of aggregated units before shipment, once work orders are closed.
ATS is already installed and in full production on over 250 production lines in Turkey (the first country to enforce complete Track & Trace regulations) and in Europe.
This agreement follows a long record of cooperation between Antares and Cognex on several large Track & Trace projects in the pharmaceutical industry.
“We successfully cooperated with Cognex on several large projects related to Track&Trace. This agreement furthers Antares long-term vision of empowering the ATS system through leading edge technology, promoting an open architecture where the customer is able to choose from a wide range of line devices and can easily interface with several vendors’ platforms.” said Adriano Fusco, Antares Vision Marketing manager.
“Collaborating with Antares Vision dramatically broadens the market potential of our cameras in the pharmaceutical industry, and gives to our European partners access to the most performing Track & Trace platform. This agreement is particularly important as Track & Trace regulations are currently under enforcement by several governments in order to face drug counterfeiting” according to Olivier Féraille, Cognex Sales Manager South Europe.
ANTARES VISION
The headquarter in Brescia, Italy, Antares Vision is European leader in offering innovative technology solutions for the security and Traceability to the pharmaceutical industry.
Its range spaces from traditional Blister filling controls, OCR/OCV readers and verifiers, to leading edge high end controls, such as complete capsule and tablet inspection machines.
All products and solutions comply with GAMP5 and 21CFR part 11 directive of the FDA. Antares Vision is the technology partner in artificial vision solutions for leading packaging producers such as the IMA group – world leader in pharmaceutical packaging.
Customer satisfaction, a global approach to in-line and off-line quality control issues, creative use of the most innovative technologies in order to supply reliable, long-lasting and user friendly solutions: these are the distinguishing features of ANTARES VISION.
COGNEX
Cognex Corporation designs, develops, manufactures and markets machine vision sensors and systems, or devices that can "see." Cognex vision sensors and systems are used in factories around the world where they guide, inspect, gauge, identify and assure the quality of a wide range of items during the manufacturing process. Cognex is the world's leader in the machine vision industry, having shipped more than 600,000 machine vision systems since the company's founding in 1981. Headquartered in Natick, Massachusetts, USA, Cognex has regional offices and distributors located throughout North America, Japan, Europe, Asia and Latin America. For details, visit Cognex on-line at www.cognex.com.
Quality
Management Software for the Blood and Tissue Industries
Blood centers and blood and tissue manufacturers
are regulated by strict quality requirements to
ensure the safety of the world's blood supply.
Sparta Systems' TrackWise enterprise quality management
software (FDA compliance software) enables these
organizations to improve compliance, increase
quality and reduce costs by centralizing and integrating
all quality processes, including customer complaints,
supplier quality, internal and external audits,
change control, corrective and preventive actions
(CAPA), preventive maintenance and calibration,
training management and document management.
TrackWise quality management software (FDA compliance
software) enables organizations to efficiently
manage and enforce current good manufacturing/laboratory/clinical
practices (cGxPs), compliance guidelines from
regulatory agencies and industry associations
such as the FDA and AABB (American Association
of Blood Banks) and organizational SOPs. With
TrackWise, all issues, actions and changes reside
in a single, easy-to-configure, web-based system
that integrates quality information between quality
assurance (QA), donor collections, hospital services,
laboratory services and other departments.
Sparta Systems offers rapid deployment solutions
that enable small- to medium-size organizations
quickly and easily migrate from paper-based systems
and spreadsheets to an automated, electronic quality
management system.
Benefits:
Boost ROI and improve efficiency as a result
of streamlined processes
Centralize data management and reporting through
consolidated tracking and workflow management
Facilitate compliance with regulatory mandates
and industry guidelines
Provide reports such as the FDA's biological
product deviation reporting (BPDR) to regulatory
agencies on a timely basis
Automatically generate reports in electronic
format from structured audit-trailed data fields
that meet industry and regulatory guidelines
Increase operational transparency through
automated alerts and extensive reporting capabilities
featuring dashboards and executive overviews
About Sparta Systems, Inc.
Sparta Systems provides companies in highly regulated
industries with a complete technology solution
that manages quality-related risk across their
enterprise and their critical supplier networks.
The company's flagship Enterprise Quality Management
Solution (EQMS), TrackWise, is purpose-built to
address the broadest possible range of quality
processes and implemented by proven industry experts.
Bacteria
shed light on new drug targets for inherited cancers
CANCER RESEARCH UK scientists have succeeded
in purifying a protein found in bacteria that
could reveal new drug targets for inherited breast
and ovarian cancers - and other cancers linked
to DNA repair faults. The study is published in
the journal Nature today (Sunday)*.
The team, based at Cancer Research UK's Paterson
Institute in Manchester, are the first to decipher
the structure of a protein called PARG - which
plays an important role in DNA repair and acts
in the same pathway as PARP.
PARP inhibitors have been showing great promise
in clinical trials for patients with breast, ovarian
and prostate cancers caused by mutations in genes
called BRCA1 and BRCA2. They work by blocking
the action of PARP - a protein that chemically
tags areas of DNA damage to highlight them to
the cell's DNA repair machinery.
PARG removes these chemical tags after the DNA
damage has been repaired. So the researchers believe
that, similar to PARP inhibitors, drugs designed
to block the action of PARG could be effective
in treating cancer.
Lead author Dr Ivan Ahel, based at Cancer Research
UK's Paterson Institute in Manchester, said: "For
decades scientists have wanted to find out the
structure of PARG, but its large size makes it
very hard to produce in the lab. By studying a
smaller version of PARG found in bacteria, we've
been able to create a '3D map' that researchers
can use to understand more about how PARG works.
The next step will be to investigate whether drugs
that block its activity might be an effective
way of treating cancers driven by faults in DNA
repair genes."
Dr Julie Sharp, senior science information manager
at Cancer Research UK, said: "This discovery
shows that bacteria and humans share similarities
in the cellular machinery they use to repair damaged
DNA. Importantly, knowing the structure of PARG
in bacteria could help researchers design targeted
treatments that are also effective in cancer patients.
We hope this will lead to further treatment options
for patients with a range of cancers in the future.
PARP Inhibitors
Cancer Research UK scientists have played a central
role over the past two decades in developing PARP
inhibitors, which are showing promise in clinical
trials.
PARP inhibitors work by preventing cancer cells
from repairing certain types of damage to their
DNA. Most healthy cells have other ways of repairing
DNA damage so they aren't affected by the drugs,
but cancer cells with faulty BRCA1 or BRCA2 genes
can't carry out these repairs. So by knocking
out both DNA repair mechanisms, the cancer cell
has no means of repairing damaged DNA. This causes
it to die, while leaving healthy cells unharmed.
Cancer Research UK is the world's leading
cancer charity dedicated to saving lives through
research
The charity's groundbreaking work into the
prevention, diagnosis and treatment of cancer
has helped save millions of lives. This work
is funded entirely by the public.
Cancer Research UK has been at the heart of
the progress that has already seen survival
rates double in the last forty years.
Cancer Research UK supports research into
all aspects of cancer through the work of over
4,000 scientists, doctors and nurses.
Together with its partners and supporters,
Cancer Research UK's vision is to beat cancer.
For further information about Cancer Research
UK's work or to find out how to support the charity,
please call 020 7121 6699 or visit www.cancerresearchuk.org
Merck
Serono, a division of Merck KGaA, Successfully Rolls
Out PAS-X MES in Mexico
Lueneburg, Germany, 28. July, 2011 -Merck Serono
and Werum Software & Systems have jointly
implemented PAS-X, Werum's Manufacturing Execution
System (MES) for the manufacturing of solids and
liquids at Merck Serono's pharmaceutical plant
in Mexico. This takes the company one step further
in rolling out PAS-X as the standard MES system
for its global pharmaceutical operations.
The new PAS-X MES at the Naucalpan plant (near
Mexico City) replaces the former paper-based production
control procedures with an electronically- based
process. A new weighing system replaces the current
weighing system.
It was also one of Merck Serono's main priorities
to interface the MES with the company's global
SAP ERP system.
The functions of the new PAS-X MES cover the
entire manufacturing process, from weighing &
dispensing, tabletting and filling of liquids
right through to packaging. Merck Serono Mexico
expects an increase in efficiency similar to that
experienced with the introduction of PAS-X in
Darmstadt, Germany, in 2008. Electronic Batch
Records based on electronic "review by exception"
effect significant time savings and a considerable
improvement in quality ("right first time").
About Werum Software & Systems
Werum
is an internationally leading supplier of Manufacturing
Execution Systems (MES) for the pharmaceutical
and biopharmaceutical industries. It’s successful
and well-established MES product PAS-X is used
by 16 of the world's top 30 pharmaceutical and
biotech companies in more than 500 installations.
Werum delivers PAS-X as a turnkey, integrated
and ready-to- be-validated system. The comprehensive
range of functions built into PAS-X is the key
to quality and compliance and lays the foundation
for operational excellence initiatives in the
manufacturing and packaging of pharmaceutical
products. The company's MES-related services include
consulting, project management, validation support,
system integration, training, maintenance, hotline
support, and life cycle management. A global network
of local Werum offices and carefully selected
regional solution partners guarantees reliable
on-site support for clients. Founded in 1969,
the IT company employs more than 400 people at
its headquarters in Lueneburg, Germany, and at
eight other locations in Germany, France, the
United States, Japan, and Singapore.
For more information on Werum and PAS-X, take
a look at our website at www.pas-x.com.
SpringFire
Laboratory NetworkAdds Atherotech to Network of
Affiliate Laboratories
Agreement Adds Advanced Lipid Testing to
SpringFire’s Clinical Research Offering
AUSTIN, Texas — July 25, 2011 —SpringFire
Laboratory Network has announced the addition
of Atherotech
Diagnostics Lab to its network of affiliate
laboratories, which provides specialized testing
services to clinical trial sponsors and clinical
research organizations (CROs). The agreement adds
Atherotech’s cardiometabolic testing services,
including the patented VAP® (Vertical Auto
Profile) advanced lipid profile, to SpringFire’s
offering.
"We are very excited about the addition of Atherotech
to the SpringFire network of laboratories," said
Jim McClintic, Managing Partner of SpringFire
Laboratory Network. "The marketplace is in need
of additional experienced esoteric laboratories
to meet the growing demand for clinical research
services."
McClintic said high complexity laboratories such
as Atherotech are in great demand in the clinical
trials market. They offer rapid turnaround times,
competitive pricing and professional consultation
on protocol development with clinical trials experience.
"Atherotech’s expertise and resources will
be a significant asset to researchers seeking
timely and accurate, directly measured lipid testing.
We look forward to putting our experienced SpringFire
sales team to work for Atherotech and their outstanding
testing services," McClintic continued.
Atherotech offers researchers more than fifty
cardiovascular and metabolic tests and is the
only laboratory that performs the VAP Cholesterol
Test, a directly measured assessment of all major
lipoprotein classes (HDL, LDL, VLDL, IDL and Lp(a))
and their important subclasses, including HDL2,
HDL3, LDL1 – LDL4, apoB, apoA1 and the apoB/apoA1
ratio. The VAP profile also provides LDL subclass
pattern (A, A/B or B) and remnant lipoprotein
cholesterol.
"This partnership will further expose the VAP
Test to the clinical trial marketplace," said
Michael Mullen, CEO of Atherotech. "SpringFire’s
experience in business development and customer
service with both clinical trial sponsors and
CROs will be an asset to Atherotech as we focus
on promoting accurate, directly measured lipid
testing."
With a combined menu of more than 1,000 specialty
tests, SpringFire offers sponsors and CROs expertise
and testing services in numerous therapeutic areas,
including anatomical pathology, molecular genetics
and women’s health.
About SpringFire Laboratory Network SpringFire’s management team has over
60 years of combined experience within the clinical
development marketplace. SpringFire Laboratory
Network is unique in representing a network of
independent, esoteric, high complexity laboratories
collectively providing testing offerings to the
clinical trial marketplace. SpringFire Laboratory
Network’s sole purpose is to match pharmaceutical,
medical device, and biotech companies with highly-regarded
clinical laboratories with years of clinical trials
experience in order to provide superior clinical
trial testing solutions. The SpringFire network
of laboratories collectively represent over 90
years of experience in the clinical marketplace
while successfully completing more than 250 clinical
trials.
Atherotech Diagnostics Lab joins the existing
SpringFire Laboratory Network which includes GI
Pathology, a gastrointestinal specialty laboratory
based in Memphis, Tenn.; D-Path, a dermatopathology
laboratory also based in Memphis, Tenn.; Pathology
Consultants of America (PCA) Southeast, a women’s
health and genitourinary pathology practice in
Columbia, Tenn.; Baylor College of Medicine’s
The Molecular Genetics Laboratories (MGL), which
provides comprehensive genetic diagnostic laboratory
services in Houston; and ITxM Diagnostics, a coagulation
laboratory in Pittsburgh. For more information,
visit www.SpringFireLabs.com.
About Atherotech Diagnostics Lab Atherotech is a CLIA-certified clinical reference
laboratory and cardiodiagnostic company focusing
on cardiometabolic tests, including the company’s
patented VAP Cholesterol Test, which reports the
cholesterol content of all lipids, components
and subclasses. The VAP Test is the first cholesterol
profile to comply with updated National Cholesterol
Education Program ATP III recommendations for
direct LDLc measurement, which is accurate with
non-fasting samples. For more information, visit
www.Atherotech.com.
Roquette
announces the completion of its new injectable carbohydrate
plant at its Lestrem facility
Carbohydrates for injectable use are highly controlled
pharmaceutical active ingredients that are essential
in the preparation of large volume parenterals.
These crucial lifesaving medicines are taken for
granted in all public health organisations and
institutions.
The large volume injectable solutions prepared
with these carbohydrates, mainly glucose solutions,
are the sort of mass medication that is expected
to be available everywhere and always of the highest
quality. Poor quality or supply chain issues can
lead to critical situations, which might endanger
lives.
The paradox for carbohydrate producers is that
these highly specialized and regulated ingredients
are small scale when compared to the wider portfolio
of products from the starch biorefinery industry
and organic growth is limited. This is further
compounded by health suppliers, hospitals and
clinics regarding them as commodities and as such
a preferred target for price reductions.
Such a niche market is a challenging environment
for investment. Roquette however, decided to proceed
with the investment as part of its long term strategy
to remain a responsible supplier in this demanding
field. In fact, Roquette has pioneered the development
of dextrose grades for the preparation of injectable
and dialysis solutions over many decades and is
the leader in the manufacturing of such carbohydrates
in Europe.
This leadership position comes with a sense of
corporate responsibility to ensure the continuity
of these vital products and this in turn has lead
to continuous investment and an identical facility
in the USA for international supply backup options.
The completion of the most recent investment
phase at Lestrem on its injectable carbohydrate
facility has just been announced. This major capital
investment which was approved in 2008 will support
the increasingly sophisticated demands of the
injectable industry in terms of quality. The facility
will be of GMP standard, as the previous one,
so that the integration into current production
capacity will be seamless though 2011.
Such a major investment is a showcase for ROQUETTE
not only in terms of its manufacturing and engineering
expertise but also of its understanding of the
high quality required and proactive knowledge
of changing European regulations to meet long
term demand for these life saving medicines.
Structural
work completed on new Ravensburg-area Vetter facility
State-of-the-art center for visual inspection
and logistics on schedule for launch
Structural
work completed: Vetter’s state-of-the-art
center for visual inspection and logistics
Ravensburg, May 18, 2011 – Structural work
on Vetter's new German facility Ravensburg Vetter
West has been completed within eleven months of
groundbreaking. As scheduled, the company concluded
structural work on its center for visual inspection
and state-of-theart high-bay warehouse for cold-storage
and room-temperature products. Interior work and
the construction of an environmentally friendly
power supply system will be finished by late 2011,
when operations will begin. In addition to photovoltaics
and biogas, the facility will also use geothermal
sources of power. More than 20 companies from
the region participated in the implementation
of the 31-million-Euro project. The facility will
employ more than 230 staff.
With its new center for visual inspection and
logistics, located in the industrial area of Erlen,
adjacent to Ravensburg, Vetter further meets the
needs of its international customers. The facility
offers optimized quality control processes and
material supply, enabling even more efficient
and reliable product delivery around the world.
To respond to the growing demand for stability
tests, the center will offer advanced-design stability
chambers, with expanded capacity for long-term
stability testing under a range of temperatures.
The facility will harness renewable energy across
the site: Vetter is installing photovoltaic cells
on the facade to generate solar electricity. The
company is also collaborating with regional farmers
who run, exclusively for Vetter, a biogas plant
used to operate a block heating and power plant
within the company’s site. Geothermal energy
will be used to regulate temperatures in the highbay
warehouse.
"Our new facility in Erlen reinforces Vetter's
position in international markets," says
Thomas Otto, Vetter Managing Director. "It
combines efficiency and sustainability, and its
advanced processes support a high level of product
and delivery security. Our investment both in
the facility and in renewable energy testifies
to our commitment to the region. In Erlen, we
are laying important groundwork for Vetter's continuing
growth and success on the world market."
About Vetter:
Vetter is an independent international specialist
in the aseptic filling of syringes, cartridges
and vials. The company has extensive experience
with a broad array of substances, including monoclonal
antibodies, peptides, interferons and vaccines.
Headquartered in Ravensburg, Germany, Vetter provides
support for pharmaceutical and biotech clients
from preclinical development through regulatory
approval and global market supply. Vetter’s
new Chicago facility, an expansion of Vetter Development
Service, supports earlystage products. The firm
works with the world’s leading pharmaceutical
and biotech companies and employs approximately
2,400 staff across Europe and the United States.
The innovator of the Vetter Lyo- Ject® dual-chamber
syringe and V-LK® cartridge, the company holds
nearly 140 patents and is a leader in the use
of RABS technology in cleanrooms. Approved as
a foreign manufacturer by the government of Japan,
Vetter’s global regulatory experience includes
numerous customer product approvals by the FDA,
EMA and other authorities. Over its more than
25-year history in aseptic filling, Vetter has
won many awards for its facilities and operations,
including the 2010 SAP EMEA Quality Award, silver
medal, for the implementation of a companywide
planning software system.
For more information contact:
Vetter Pharma International GmbH
Oskar Gold
Eywiesenstrasse 5
88212 Ravensburg
Germany phone: +49-(0)751-3700-3729
fax: +49-(0)751-3700-7707
e-mail: press@vetter-pharma.com www.vetter-pharma.com
Screening
compound resynthesis services from Chemonaut and
iThemba Pharmaceuticals
iThemba Pharmaceuticals and Chemonaut announce
a collaboration on providing a screening compound
re-synthesis service. The collaboration has stemmed
from both companies recognising that in the dynamically
changing world of screening compound supply, it
has become more difficult to resource hit compounds
from their original source.
Chemonaut has implemented a resynthesis inquiry
procedure for situations where a structure query
results in no matching compounds being available
in the database of more than 5 million in-stock
compounds. After submitting the inquiry form,
the scientists at iThemba will automatically provide
you a highly competitive quotation for resynthesis
with a fast turn around time.
Commenting on the collaboration, Chemonaut’s
Managing Director, Ron van der Valk, said “The
resynthesis service underlines the commitment
to our clients by providing them with a practical
solution that facilitates rapid follow-up in the
hit-to-lead process. The excellent scientists
of iThemba have already shown on several occasions
that they deliver on their promises, so we are
glad to formalise this partnership and promote
the resynthesis service on our online compound
sourcing portal.”
iThemba’s CSO,Chris Edlin, commented “iThemba
is excited to be entering into this collaboration
with Chemonaut and is committed to providing world
class chemical synthesis capacity backed up by
our hands-on Scientific Advisory Board”
Rising
Stars in the Chemistry/Biochemistry Department at
U.T.
Arlington are the Second Winners of a SPECTROstar
Nano from BMG LABTECH
For young and exuberant scientists it is sometimes
hard to accomplish new and exciting research when
applying for classic funding sources. Often there
may be limited interest in the research subject
at that time or proposals are just too risky for
funding.
In order to address their need for a new absorbance
microplate reader for teaching and in their labs,
researchers at the University of Texas at Arlington
decided to pull their new and innovative ideas
together to apply for BMG
LABTECH’s SPECTROstar Nano competition.
Combining their ideas into one proposal helped
to mitigate the risk of submitting just one idea
and it also helped to show how six different laboratories
can use one instrument for a myriad of applications.
To find out how they propose to use the SPECTROstar
Nano to redefine absorbance measurements at UTA,
you can read their winning proposal on our website
at www.bmglabtech.com/promotion/second-winner.cfm.
Dr. Kevin Schug, one of the scientists at UTA
is thrilled to hear that their proposal was chosen.
"At the Department of Chemistry & Biochemistry
in the University of Texas at Arlington, we have
a significant number of junior faculty who are
pursuing new and innovative research and teaching
approaches. The award of a SPECTROstar Nano system
gives us many new capabilities, which we previously
lacked. Not only will we be able to use the instrument
for a wide range of research and teaching efforts,
the instrument will provide support for the advancement
of our junior faculty in their academic careers,
as well as exposure to students of state-of-the-art
instrumentation. We are extremely excited about
the prospects that this award has afforded, and
we appreciate the opportunity given by BMG LABTECH
to compete for this instrument."
If you, like the young professors at UTA, have
a great idea for the SPECTROstar Nano, submit
your entry before the third winner is chosen next
month. Simply write a short 2-4 page proposal
on how your lab would use this new and unique
instrument. Its proprietary ultra-fast spectrometer
instantaneously captures a full UV-Vis spectrum
in microplates, cuvettes and low volumes samples.
Fast, full spectrum measurements will redefine
the most common absorbance assays such as ELISAs,
DNA, RNA, Protein (Bradford, BCA, Lowry), cell
growth, and beta-galactosidase.
Tell us how you propose to use the SPECTROstar
Nano in a unique fashion or one of the instrument’s
many unique features such as: full UV/Vis spectrum
per well, gas vent for atmospheric control, 1536
well plate reading capability, incubation and
shaking, reference corrections to improve data,
cuvette and plate kinetics, BMG LATECH’s
low volume LVis Plate, or robotic interface mode.
For more information go to www.bmglabtech.com/promotion or ask
your local BMG LABTECH representative.
Don’t forget to submit your proposal before
May 15th to qualify to win the third
of five SPECTROstar Nanos from BMG LABTECH.
CARBOGEN
AMCIS AG Announces Containment Performance Validation
External Qualification to Evaluate Safe Handling
of Highly Potent APIs
BUBENDORF, Switzerland (April 28, 2011) - CARBOGEN
AMCIS AG has announced that its commercial
facility for multi-purpose production of highly
potent Active Pharmaceutical Ingredients (APIs)
has fully met all design specifications for the
containment of highly active APIs. The facility,
located on the site of its parent company, Dishman
Pharmaceuticals and Chemicals Ltd., in Ahmedabad,
India, limits worker exposures to <1 µg/m3
(8hr-TWA)[1] and is thus capable of manufacturing
compounds of the highest occupational exposure
band (Category IV), which includes, for example,
IARC[2] Category 1 carcinogens. Performance within
the design specification was verified through
application of industry standard surrogate testing
designed to evaluate the safe handling of highly
potent APIs.
"This is an important milestone for CARBOGEN
AMCIS and the Dishman Group. We have successfully
undergone an in-depth and scientifically rigorous
qualification process of our containment equipment,
led by an external consultancy with a strong reputation
and expertise in industrial hygiene," said
Charlie Johnson, Head of High Potency Business
Unit, CARBOGEN AMCIS AG.
The containment performance validation was completed
on-site by VEGA
Environmental Consultants Ltd., the independent
UK-based industrial hygiene consulting company.
Containment testing was performed according to
ISPE's[3] SMEPAC-guideline,[4] a widely accepted
standard in the pharmaceutical industry. Isolators
for solid handling operations in the high potency
manufacturing suites were challenged using a surrogate
substance and operator exposures were measured
to be below 0.1 µg/m3 calculated as an 8hr-time
weighted average.
This result ensures that CARBOGEN AMCIS meets
current industrial standards for the safe handling
of highly potent solids in the evaluated containment
areas.
CARBOGEN
AMCIS AG is a leading service provider, offering
a portfolio of drug-development and commercialization
services to the pharmaceutical and biopharmaceutical
industry at all stages of drug development. The
integrated services provide innovative chemistry
solutions to support timely and safe drug development
allowing customers to make the best use of available
resources. CARBOGEN AMCIS AG is owned by Dishman
Pharmaceuticals and Chemicals Ltd., Ahmedabad,
India.
Dishman
Group is a global outsourcing partner for
the pharmaceutical industry, offering a portfolio
of development, scale-up and manufacturing services.
Dishman Group improves its customers' businesses
by providing a range of development and manufacturing
solutions at locations in Europe, China and India.
VEGA
Environmental Consultants Ltd. is a UK-based
leading occupational hygiene and environmental
consultancy company offering services for the
diagnosis, interpretation and resolution of complex
environmental problems for clean room performance,
occupational hygiene assessment and environmental
testing.
Vetter’s
Chicago facility now accepting projects Staffing
strategy ensures consistent quality and processes
Ravensburg / Skokie, April 28, 2011 – Vetter,
a leading provider of aseptic prefilled drugdelivery
systems, today announced that its Chicago facility
is accepting client projects. Located at the Illinois
Science + Technology Park in Skokie, Illinois,
the site supports preclinical through phase II
products. The facility provides cGMP filling for
vials, syringes and cartridges. Processes used
at Vetter’s Chicago operations are based
on those of existing Vetter facilities. The site
is staffed in large part by experienced professionals
from Vetter’s German facilities. Some of
these personnel will be replaced by local professionals
as they are hired and trained in Vetter best practices.
This train-and-replace strategy helps ensure seamless
performance across Vetter sites.
Chicago facility functional areas include qualification
and validation, engineering, microbiology lab,
chemical analysis lab, materials preparation,
compounding, aseptic filling, visual inspection,
quality assurance, supply chain and the administrative
office. German employees currently staff a majority
of positions, while local professionals are hired
and trained. Local staff hired to work in the
microbiology and chemical analysis labs receive
part of their training at Vetter’s existing
facilities. Those working in the manufacturing
area train on local equipment at the Chicago facility.
Experienced project managers steer all tasks and
processes, which is a major success factor in
early-phase work.
Over the next two to three years, local professionals
are expected to replace some of Vetter’s
German employees in Chicago. “Our train-and-replace
strategy underscores Vetter’s dedication
to consistency and quality, which our customers
trust us to deliver,” explains Vetter Managing
Director Peter Soelkner. “This approach also
helps ensure a seamless transfer from Chicago
to our commercial manufacturing facilities, once
products reach phase III.”
The 24,000-square-foot Chicago facility houses
cleanrooms, chemical analysis lab, microbiology
lab, cGMP storage area and administrative offices.
It is located in a thriving industrial and academic
center that offers a talent pool of 70,000 to
80,000 highly skilled professionals. Site manager
Dr. Claudia Roth has extensive experience designing
and establishing clinical manufacturing lines,
including freeze-drying operations.
Vetter´s new Chicago facility is an expansion
of Vetter Development Service, one of the company’s
three service divisions, along with Vetter Commercial
Manufacturing and Vetter Solutions. Vetter Development
Service employs more than 100 personnel in Europe
and the United States and supports customer products
from preclinical development through market launch.
Its service portfolio includes, among others,
primary and secondary packaging development, process
development, clinical manufacturing, regulatory
affairs services, and seamless product transfer
to Vetter Commercial Manufacturing.
Last year, Vetter relocated its North American
sales office to the Illinois Science + Technology
Park, further enhancing the company’s ability
to serve its customers quickly and efficiently.
Proximity to major airports and a metropolitan
train station at the park, coming soon, enables
customers easy access and underscores Vetter’s
emphasis on partnership and its dedication to
serving the North American market.
About Vetter:
Vetter is an independent international specialist
in the aseptic filling of syringes, cartridges
and vials. The company has extensive experience
with a broad array of substances, including monoclonal
antibodies, peptides, interferons and vaccines.
Headquartered in Ravensburg, Germany, Vetter provides
support for pharmaceutical and biotech clients
from preclinical development through regulatory
approval and global market supply. Vetter’s
new Chicago facility, an expansion of Vetter Development
Service, supports earlystage products. The firm
works with the world’s leading pharmaceutical
and biotech companies, and employs approx. 2,400
staff across Europe and the United States. The
innovator of the Vetter Lyo-Ject® dual-chamber
syringe and V-LK® cartridge, the company holds
nearly 140 patents and is a leader in the use
of RABS technology in cleanrooms. Approved as
a foreign manufacturer by the government of Japan,
Vetter’s global regulatory experience includes
numerous customer product approvals by the FDA,
EMA and other authorities. Over its more than
25-year history in aseptic filling, Vetter has
won many awards for its facilities and operations,
including the 2010 SAP EMEA Quality Award, silver
medal, for the implementation of a companywide
planning software system.
For more information contact:
Vetter Pharma International GmbH
Oskar Gold
Eywiesenstrasse 5
88212 Ravensburg Germany phone: +49-(0)751-3700-3729 fax: +49-(0)751-3700-7707 e-mail: press@vetter-pharma.com web:
www.vetter-pharma.com
Derrington
Named President and COO at MPI Research
Mattawan, Mich. (March 4, 2011)
– MPI Research, the largest single-site
preclinical contract research organization worldwide,
is pleased to announce that Tim Derrington is
joining the company as President and Chief Operating
Officer, effective March 7, 2011.
Derrington brings a wealth of international operational
and industry leadership, experience, and specific
knowledge for maximizing operational performance,
business development, and strategic partnerships.
He most recently was Chairman and CEO of Axient
Research, a CRO developing clinical research solutions
to deliver reliable and accurate patient data
to accelerate the development of safe and effective
drug and medical treatments.
Prior to Axient, Derrington was the CEO of BioReliance
Corp (Invitrogen Corp), a research company providing
biologic testing and manufacturing and toxicology
services to global pharmaceutical and biopharmaceutical
companies that span the product cycle from early
preclinical development to licensed production.
Over the duration of his career, he has held management
positions with Quintiles Transnational Corp (Senior
Vice President, Corporate Development); Quintiles
Laboratories Worldwide (Chief Operating Officer);
Mayo Clinic (Administrative Director-Clinical
Trials); and Shell UK Ventures (Managing Director
and Project Manager).
Derrington is a graduate of Seale Hayne College,
England, and holds an MBA from Henley Management
College, Oxfordshire, England.
According to MPI Research Chairman and CEO, William
U. Parfet, "As President and COO, Tim Derrington
will help us scale our operations and expand our
presence globally. He represents the depth that
is essential to our top management team, and his
knowledge, leadership ability, and industry experience
will be among our most valuable assets."
Please join us in welcoming Tim Derrington to
MPI Research!
MPI Research, with global headquarters in Mattawan,
Michigan, provides safety evaluation, discovery,
bioanalytical, and analytical services to the
biopharmaceutical, medical device, animal health,
and chemical industries. Scientific knowledge
and experience, responsiveness, integrity, trust,
teamwork, and dedication to strong and enduring
Sponsor relationships are the defining attributes
that characterize MPI Research as a high-performance,
high-quality organization that is committed to
bringing safer and more effective products to
the world. Learn more about how we can exceed
your expectations at www.mpiresearch.com.
54943 North Main Street
Mattawan, MI 49071
Phone: +1-269-668-3336
Fax: +1-269-668-4151 www.mpiresearch.com
PAS-X:
More than Execution in Manufacturing & Packaging?
Lueneburg, Germany, October 15, 2010 –
The 12th PAS-X User Group Meeting took place from
30 September to 1 October in Lüneburg and
saw, once again, an increase in participants over
last year's meeting. More than 180 international
guests from 18 countries followed Werum's invitation
and made for another record attendance.
Hartmut Krome, Chairman of Werum's Executive
Board, explained the motto of the present year's
meeting like this: "Based on our core area
'Execution in Manufacturing and Packaging' we
are looking to expand our solutions in future
to the more comprehensive field of 'Manufacturing
IT'."
An important future field of activity in this
context is Process
Development: dealing with the use of Werum's software
in the phase between research and the start of
commercial production.
The lectures centered again around most interesting
real-life reports about day-to-day practice –
including in this year reports from Amgen, Bayer
HealthCare, Boehringer Ingelheim and CSL Behring.
Also, the PAS-X User Forum presented its activities
in Europe and the USA.
Inside knowledge into the GAMP MES Good Practice
Guide and Operational Excellence complemented
the program of the meeting.
Werum chose the 'Miniature Wonderland' in Hamburg's
Dockland Warehouse District as the location for
the social evening event. The largest model railway
in the world provided an exciting and truly international
setting for relaxed networking.
About Werum Software & Systems
Werum is the international leading supplier of
Manufacturing Execution Systems (MES) for the
pharmaceutical and biopharmaceutical industries.
Its successful and well-established MES product
PAS-X is installed at 16 of the world's top 30
pharmaceutical and biotech companies. The comprehensive
range of functions built into PAS-X is the key
to quality and compliance and lays the foundation
for operational excellence initiatives in the
manufacturing and packaging of pharmaceutical
products. The company's MES- related services
include consulting, project management, validation
support, system integration, training, maintenance,
hotline support, and life cycle management. The
software provider supplies turnkey, integrated
and ready-to-be-validated Manufacturing Execution
Systems. A global network of local Werum offices
and carefully selected regional solution partners
guarantees reliable on-site support for clients.
Founded in 1969, the IT company employs more than
400 people at its headquarters in Lueneburg, Germany,
and at eight other locations in Germany, France,
the United States, Japan, and Singapore.
For more information on Werum and PAS-X, take
a look at our website at www.pas-x.com.
Illustrating Graphics
The following graphics are available to illustrate
this article:
- Werum User Group Meeting 2010
Free
virtual event focusing on multi-industry cutting
edge sensor technology.
Billerica, MA, USA – 5 October 2010 –
The global sensor market is a dynamic space, constantly
evolving as technology and industry policy change.
Attendees of "Critical Information for Real
Time Decisions," a free virtual event, will
have the opportunity to learn from peers and industry
experts about the latest sensor technologies within
their industries. One tiny sensor can ensure that
a sleep apnea machine is functioning correctly
or your car tires are properly inflated to help
you save fuel efficiency and possibly avoid an
accident. Attendees can listen to presentations
on topics such as integrating CO2 sensors for
increased building efficiency to designing and
integrating wireless sensor networks in a pharmaceutical
setting and much more. If it's related to the
sensor space, you will find it at "Critical
Information for Real Time Decisions."
Come and join us on Tuesday, October 19 to learn
more about how sensor technology is evolving and
how it is put to use in applications from healthcare
and pharmaceuticals to buildings' efficiency and
the automotive sector. The live event will open
at 12 noon CET (Central European Time) to 22.00.
CET and the environment will be online until December
2010, so attendees can re-visit the site after
the live day to get any information they miss.
The event agenda includes keynote speakers from
leading industry organizations and live Q&A
sessions following each presentation. Once inside
the virtual environment, attendees can access
discussion forums and network with other professionals.
In addition, industry experts from GE will be
on hand throughout the virtual environment to
chat with you and answer any questions you might
have about different kinds of technologies, products
or applications.
Keynote schedule for October 19:
Session 1:. 14.00 CET
MEMS Sensors & Actuators for Harsh Environments
& Wireless Operation
Ertugrul Berkcan
Principal Scientist; GE Global Research Center
Session 2: 16.00 CET
CO2 Sensors for Energy Savings & Improved
Indoor Air Quality
Don Adams
Kele , Inc.
Session 3: 17.30 CET
Analysis of Sensors in the Medical Applications
Market
Dr. Rajender Thusu; Senior Industry Analyst, Sensors
& Instrumentation
Frost & Sullivan
Session 4: 20.00 CET
From Smart Dust to Smart Planet: Designing Robust
Wireless Sensor Networks
Dr. Kris Pister, Founder and Chief Technology
Officer
Dust Networks
About Measurement & Control Solutions
Measurement & Control Solutions is a leading
innovator in advanced, sensor-based measurement,
non-destructive testing and inspection and condition
monitoring, delivering accuracy, productivity
and safety to a wide range of industries, including
oil & gas, power generation, aerospace, transportation
and healthcare. It has over 40 facilities in 25
countries and is part of GE Energy Services, which
provides cleaner, smarter, more efficient solutions
for its customers. For further information, visit
www.gesensinginspection.com
About GE Energy
With nearly 85,000 global employees and 2009 revenues
of $37 billion, GE Energy
www.ge.com/energy is one of the world's leading
suppliers of power generation and energy delivery
technologies. The businesses that comprise GE
Energy—GE Power & Water, GE Energy Services
and GE Oil & Gas—work together to provide
integrated product and service solutions in all
areas of the energy industry including coal, oil,
natural gas and nuclear energy; renewable resources
such as water, wind, solar and biogas; and other
alternative fuels.
Media Contact Amanda Fontaine
GE Energy
Measurement & Control Solutions
+1 978 437 1446 amanda.fontaine4@ge.com
New
generation of ultra pure crospovidone for the pharmaceutical
industry.
Paris, France (October 5, 2010) - ISP today
announced that a new generation of ultra pure crospovidones
is now available to the pharmaceutical industry
on a commercial scale. The high-purity crospovidone,
sold under the trade names Polyplasdone® Ultra
and Polyplasdone® Ultra-10, will be manufactured
to standards well above commercial products currently
in the market. ISP invested heavily in a new state-of-the-art
production facility at Texas City, Texas (USA) to
produce high-purity, high-quality grades of Polyplasdone
Ultra crospovidone specifically for the pharmaceutical
industry. According to Philip Strenger, senior vice
president global pharmaceuticals, with the launch
of ultra high-purity crospovidone, the pharmaceutical
industry can now use this excipient technology for
a broader spectrum of drug formulations. "Formulators
of pharmaceuticals have long appreciated the combined
disintegrant and solubilization functionality Polyplasdone
crospovidone brings to oral solid dosage formulations,
and they have asked ISP to raise the benchmark in
purity so it can be formulated in conjunction with
virtually every drug active," he said. "Beginning
in November, ISP will offer samples of Polyplasdone
Ultra and Ultra-10 crospovidones manufactured on
commercial-scale, fulfilling the pharmaceutical
industry's request for the next generation of crospovidone
with a purity profile that will allow for use in
some of the world's most sensitive APIs. This is
a further step in strengthening the ISP tool kit
for increasing the bioavailability of poorly soluble
actives," he added. State-of-the-art production
system
Having re-engineered the production technology
for crospovidone in 2008, ISP is fully equipped
to produce the world's highest purity grades in
Texas City, Texas. The validated system is configured
for precise control of all manufacturing steps,
from the initial reaction through purification
and drying. Polyplasdone Ultra grades of high-purity
crospovidone will also be packed under nitrogen
to maintain product quality during shipping and
storage.
Superdisintegrant of choice
Crospovidone is the superdisintegrant of choice
for oral solid dosage forms of pharmaceuticals.
ISP, the supplier of Polyplasdone® XL crospovidone
(with average particle sizes of 110µm to
140µm) and Polyplasdone® XL-10 crospovidone
(with average particle sizes of 25µm to
40µm), now offers these grades in ultra
pure form. Polyplasdone Ultra and Polyplasdone
Ultra-10 grades have significantly lower peroxide
levels than standard forms of crospovidone. These
high purity grades have peroxide levels of more
than ten times lower than standard forms of crospovidone
and have more stringent specifications than current
requirements of the European Pharmacopeia monograph
for crospovidone. "The higher purity and
quality of crospovidone coming off ISP's production
system is proof that a new benchmark is set for
this extraordinary excipient technology,"
Strenger said. Plant qualifications
All of ISP's Polyplasdone® crospovidone products
have received the United States Pharmacopeia (USP)
Verified Pharmaceutical Ingredient Mark, which
is awarded to companies and pharmaceutical ingredients
that pass all USP verification requirements, including
a comprehensive GMP audit by the USP, thorough
documentation review, and testing for purity and
potency. To request samples of Polyplasdone Ultra
and Polyplasdone Ultra-10 crospovidones, visit
isppharmaceuticals.com
About ISP International Specialty Products
Inc. (ISP) is a leading global supplier of specialty
chemicals and performance enhancing products for
a wide variety of personal care, pharmaceutical,
beverage and industrial applications. ISP produces
more than 500 specialty chemicals, which it markets
and sells worldwide. The company's headquarters
is located in Wayne, New Jersey, USA.
About ISP Pharmaceuticals ISP Pharmaceuticals
is a global business providing technology for
drug synthesis, drug solubilization, and coatings.
The business is committed to providing quality
products and services and reliable customer support
to advance the commercialization goals of the
world's largest producers of pharmaceuticals and
dietary supplements. In excipients and coatings,
ISP offers a range of products, including Polyplasdone®
crospovidone, for rapid disintegration and enhanced
drug dissolution; Advantia® Coatings Systems,
for film coating of pharmaceutical and dietary
supplement oral solid dosage forms; and Plasdone®
povidone, for high performance tablet binding.
In the area of drug synthesis, ISP Fine Chemicals
is a contract manufacturer of key starting materials,
regulated intermediates, and active pharmaceutical
ingredients. It also supplies high-purity Tetrahyrdofuran
Pharma for drug synthesis. Today, ISP has one
of the most comprehensive offerings to the pharmaceutical
industry for enhancing drug solubility. This offering
features a range of ingredients that include Plasdone®
polymers for solid dispersions. ISP Pharmaceuticals
also offers development services for spray dried
solid dispersions.
For further information:
ISP CONTACT: Ann Druffner International
Specialty Products, Inc. Tel: +1.973.628.4103
adruffner@ispcorp.com
MEDIA CONTACT: Thomas Nicolay Resource
Advantage Group, Inc. Tel: +1.973.882.1313 Fax:
+1.973.575.1720 tnicolay@resourceadvantage.com
Medisize
brings a new bottle system for the pharmaceutical
industry to the market, based on the point of "aesthetics
meets functional design packaging".
Aesthetics meets functional
design packaging - new Medisize bottle with
overcap
Medisize has developed a safe bottle and overcap
system for the healthcare market. The overcap can
be transformed by colour by dying or made transparent
making it visually impressive.
The new injection blow moulded bottle supersedes
the former extrusion blow bottle as both the quality
and dimensional accuracy is significantly increased,
combining a perfect fit of the overcap with ease
of opening. The safety function is increased as
an accidental press of the pump is excluded by
the cap as it protects the whole upper part of
the bottle and pump. The new bottle system is
based on the idea of an extended hygienic standard.
The area where liquid flows out remains uncontaminated
as the bigger overcap covers the pump completely,
thus the solution remains clean and protected
from external influences like pollution or due
to an application error.
Custom sizes and designs (oval / square) can
be developed and produced in short lead times.
The main advantages of the new injection moulded
bottle with new closure technology offers is the
simplistic packaging and safe operation while
ensuring highest hygiene protection. Other features
include a large labelling area for new application
instructions as well as opportunities for improved
visual presentation at the Point-Of-Sale.
About Medisize
Medisize's drive and innovation make us a leading
contract development and manufacturing partner
in the healthcare market. Our reputation, recognised
by clients in over forty countries, is based upon
proven expertise in product design, in-house tool
making, moulding, welding, assembly, packaging
and sterilisation.
We can be your partner for customized products
in:
Multipharma
Forges Co-operation for Supply Chain Services With
Movianto; Europe's Leading Contract Logistics Provider
Switzerland, July 16, 2010 – Multipharma
is committed to offering its clients the highest
quality standards available and therefore has
chosen Movianto as its preferred logistics provider
to cope with the increasing demand for the supply
of non-IMP's to study sites. Movianto is one of
the leading European logistics service providers
and offers customized services for its clients.
Movianto designs supply chain solutions that
anticipate and meet the challenges faced by the
pharmaceutical industry, now and in the future.
Multipharma's products will be handled at Movianto’s
state-of-the-art facility in Neunkirchen, Germany
with special emphasis on cold-chain and clinical
trial material handling. From here we can directly
supply clinical sites across Europe for next-day
delivery. With the respective licenses and processes
in place we can now also offer repackaging and
relabeling services to further meet our client's
needs.
About Movianto
The Movianto Group is committed to being the preferred
European contract logistics service provider to
the pharmaceutical, biotechnology and healthcare
industry. Offering outsourcing services along
the supply chain, such as warehousing, transportation,
cold chain logistics, as well as re-packaging
and re-labeling, Movianto’s international
clients benefit from a pan-European network, the
broad range of healthcare logistics services,
the know-how of the local markets and uncompromising
quality standards. www.movianto.com
About Multipharma
Multipharma is a Swiss based company and was founded
in 1997. Multipharma’s core business and
capabilities include supplying leading pharmaceutical
and biotechnology companies with comparators and
supplies for clinical trials; sourcing directly
from manufacturers globally with applicable compliance
documentation; providing single lots with long
expiration dating at competitive pricing; delivering
Just in Time Directly to Clinical Trial Sites;
and offering Standard of Care Supply Programs
and Depot Management Solutions. The Multipharma
executive team collectively has more than 30 years
experience in the pharmaceutical and biotechnology
industry, 20 years in clinical trials alone; providing
them with a broad understanding of the challenges
and ever-changing environment of clinical trials.
Advanced
Cyclone Systems - Solving the problem of efficient
powder recovery
Hurricane and ReCyclone® Systems
by Advanced Cyclone Systems
Solving the problem of efficient powder
recovery
Efficient recovery of Active Pharmaceutical Ingredients
(APIs) after Spray and Fluid Bed Drying is still
a problem for pharmaceutical and biopharmaceutical
companies. For the recovery of these sensible
products, cyclone collectors are frequently irreplaceable
equipments for being able to capture the powder
directly and avoiding contamination of filter
bags, as well as product degradation with temperature.
However, product losses due to cyclones’
low efficiency represents a high cost as a consequence
of the value of APIs. Many biological APIs can
achieve hundreds of thousands of Euros/kg.
Hurricane cyclones demonstrate
impressive efficiencies in capturing inhalable
powders with a Median Volume Diameter (MVD) of
less than 3-5µm. These cyclones were obtained
after years of work in partnership with the Faculty
of Engineering of Porto.
Hurricane geometries maximize powder collection
for each different application, while minimizing
re-entrainment and keeping pressure drop at reasonable
levels. A single Hurricane is more efficient than
any other known cyclone available in the marketplace
for the same pressure drop.
A ReCyclone is composed by a
Hurricane and by a particle separator (mechanical
or electrostatic re-circulator), placed downstream
of the cyclone.
The
main purpose of the recirculation is to reintroduce
the fine non-captured particles into the cyclone
after those have been driven to the outer walls
of the re-circulator by centrifugal or electrical
forces. While this tangential gas stream is enriched
in particles, the axial gas stream exhaust to
the stack is practically invisible.
Efficiency increases due to recirculation and
agglomeration of very small particles with larger
ones coming directly from the process. Emissions
from an Electrostatic ReCyclone can be as low
as those from a typical bag-filter.
Contact:
Pedro Araújo Advanced
Cyclone Systems, S.A. Phone : +351.225.322.097 Fax :
+351.225.322.096 E-mail: pedro@acsystems.pt Web :
www.acsystems.pt
InfraTrac
uses quality approach to combat drug counterfeiting
InfraTrac uses quality approach to combat
drug counterfeiting
SILVER SPRING, MD, August 10, 2009 - InfraTrac,
a product protection company with innovative anti-counterfeiting
technology, announced the release of Version 1.4
of its fingerprinting software for in-product
anti-counterfeiting. This release helps
pharmaceutical companies manage product quality
and reduce the risk of economically motivated
adulteration.
InfraTrac uses near-infrared spectroscopy for
instant, non-destructive, easy-to-use verification
that is useful throughout the supply chain, including
at the point of dispensing. Fully compliant
with U.S. FDA and EU regulations, InfraTrac provides
cost-effective covert fingerprinting on the product
itself, not just the packaging.
This new release aligns with Quality by Design
(QbD) and Process Analytic Technology (PAT) initiatives
designed to reduce manufacturing waste.
It incorporates high quality chemometric analysis,
provided by InfraTrac’s partner, CAMO.
About
InfraTrac
InfraTrac uses spectroscopy
to
detect and prevent counterfeiting of high value
formulated and regulated substances including
pharmaceuticals,
chemicals
and consumer
products. InfraTrac’s platform includes
counterfeit detection using a simple yes-no interface,
and encryption software, which enables tagging
of client substances, even at the batch level,
using patent-pending covert
NIR fingerprints. Easy-to-use field
verification makes it possible to check throughout
the supply chain.
Medisize
brings a new bottle system for the pharmaceutical
industry to the market, based on the point of "aesthetics
meets functional design packaging".
Aesthetics meets functional
design packaging - new Medisize bottle with
overcap
Medisize has developed a safe bottle and overcap
system for the healthcare market. The overcap can
be transformed by colour by dying or made transparent
making it visually impressive.
The new injection blow moulded bottle supersedes
the former extrusion blow bottle as both the quality
and dimensional accuracy is significantly increased,
combining a perfect fit of the overcap with ease
of opening. The safety function is increased as
an accidental press of the pump is excluded by
the cap as it protects the whole upper part of
the bottle and pump. The new bottle system is
based on the idea of an extended hygienic standard.
The area where liquid flows out remains uncontaminated
as the bigger overcap covers the pump completely,
thus the solution remains clean and protected
from external influences like pollution or due
to an application error.
Custom sizes and designs (oval / square) can
be developed and produced in short lead times.
The main advantages of the new injection moulded
bottle with new closure technology offers is the
simplistic packaging and safe operation while
ensuring highest hygiene protection. Other features
include a large labelling area for new application
instructions as well as opportunities for improved
visual presentation at the Point-Of-Sale.
About Medisize
Medisize's drive and innovation make us a leading
contract development and manufacturing partner
in the healthcare market. Our reputation, recognised
by clients in over forty countries, is based upon
proven expertise in product design, in-house tool
making, moulding, welding, assembly, packaging
and sterilisation.
We can be your partner for customized products
in:
Multipharma
Forges Co-operation for Supply Chain Services With
Movianto; Europe's Leading Contract Logistics Provider
Switzerland, July 16, 2010 – Multipharma
is committed to offering its clients the highest
quality standards available and therefore has
chosen Movianto as its preferred logistics provider
to cope with the increasing demand for the supply
of non-IMP's to study sites. Movianto is one of
the leading European logistics service providers
and offers customized services for its clients.
Movianto designs supply chain solutions that
anticipate and meet the challenges faced by the
pharmaceutical industry, now and in the future.
Multipharma's products will be handled at Movianto’s
state-of-the-art facility in Neunkirchen, Germany
with special emphasis on cold-chain and clinical
trial material handling. From here we can directly
supply clinical sites across Europe for next-day
delivery. With the respective licenses and processes
in place we can now also offer repackaging and
relabeling services to further meet our client's
needs.
About Movianto
The Movianto Group is committed to being the preferred
European contract logistics service provider to
the pharmaceutical, biotechnology and healthcare
industry. Offering outsourcing services along
the supply chain, such as warehousing, transportation,
cold chain logistics, as well as re-packaging
and re-labeling, Movianto’s international
clients benefit from a pan-European network, the
broad range of healthcare logistics services,
the know-how of the local markets and uncompromising
quality standards. www.movianto.com
About Multipharma
Multipharma is a Swiss based company and was founded
in 1997. Multipharma’s core business and
capabilities include supplying leading pharmaceutical
and biotechnology companies with comparators and
supplies for clinical trials; sourcing directly
from manufacturers globally with applicable compliance
documentation; providing single lots with long
expiration dating at competitive pricing; delivering
Just in Time Directly to Clinical Trial Sites;
and offering Standard of Care Supply Programs
and Depot Management Solutions. The Multipharma
executive team collectively has more than 30 years
experience in the pharmaceutical and biotechnology
industry, 20 years in clinical trials alone; providing
them with a broad understanding of the challenges
and ever-changing environment of clinical trials.
Advanced
Cyclone Systems - Solving the problem of efficient
powder recovery
Hurricane and ReCyclone® Systems
by Advanced Cyclone Systems
Solving the problem of efficient powder
recovery
Efficient recovery of Active Pharmaceutical Ingredients
(APIs) after Spray and Fluid Bed Drying is still
a problem for pharmaceutical and biopharmaceutical
companies. For the recovery of these sensible
products, cyclone collectors are frequently irreplaceable
equipments for being able to capture the powder
directly and avoiding contamination of filter
bags, as well as product degradation with temperature.
However, product losses due to cyclones’
low efficiency represents a high cost as a consequence
of the value of APIs. Many biological APIs can
achieve hundreds of thousands of Euros/kg.
Hurricane cyclones demonstrate
impressive efficiencies in capturing inhalable
powders with a Median Volume Diameter (MVD) of
less than 3-5µm. These cyclones were obtained
after years of work in partnership with the Faculty
of Engineering of Porto.
Hurricane geometries maximize powder collection
for each different application, while minimizing
re-entrainment and keeping pressure drop at reasonable
levels. A single Hurricane is more efficient than
any other known cyclone available in the marketplace
for the same pressure drop.
A ReCyclone is composed by a
Hurricane and by a particle separator (mechanical
or electrostatic re-circulator), placed downstream
of the cyclone.
The
main purpose of the recirculation is to reintroduce
the fine non-captured particles into the cyclone
after those have been driven to the outer walls
of the re-circulator by centrifugal or electrical
forces. While this tangential gas stream is enriched
in particles, the axial gas stream exhaust to
the stack is practically invisible.
Efficiency increases due to recirculation and
agglomeration of very small particles with larger
ones coming directly from the process. Emissions
from an Electrostatic ReCyclone can be as low
as those from a typical bag-filter.
Contact:
Pedro Araújo Advanced
Cyclone Systems, S.A. Phone : +351.225.322.097 Fax :
+351.225.322.096 E-mail: pedro@acsystems.pt Web :
www.acsystems.pt
InfraTrac
uses quality approach to combat drug counterfeiting
InfraTrac uses quality approach to combat
drug counterfeiting
SILVER SPRING, MD, August 10, 2009 - InfraTrac,
a product protection company with innovative anti-counterfeiting
technology, announced the release of Version 1.4
of its fingerprinting software for in-product
anti-counterfeiting. This release helps
pharmaceutical companies manage product quality
and reduce the risk of economically motivated
adulteration.
InfraTrac uses near-infrared spectroscopy for
instant, non-destructive, easy-to-use verification
that is useful throughout the supply chain, including
at the point of dispensing. Fully compliant
with U.S. FDA and EU regulations, InfraTrac provides
cost-effective covert fingerprinting on the product
itself, not just the packaging.
This new release aligns with Quality by Design
(QbD) and Process Analytic Technology (PAT) initiatives
designed to reduce manufacturing waste.
It incorporates high quality chemometric analysis,
provided by InfraTrac’s partner, CAMO.
About
InfraTrac
InfraTrac uses spectroscopy
to
detect and prevent counterfeiting of high value
formulated and regulated substances including
pharmaceuticals,
chemicals
and consumer
products. InfraTrac’s platform includes
counterfeit detection using a simple yes-no interface,
and encryption software, which enables tagging
of client substances, even at the batch level,
using patent-pending covert
NIR fingerprints. Easy-to-use field
verification makes it possible to check throughout
the supply chain.
Structure-flex
opens supply chain route with China
Melton Constable, Norfolk: in
today’s extremely difficult economic climate,
when competitors are hungry for your business,
it is of paramount importance to ensure that your
existing and potential customers can be supplied
with first-class products, on time, and at competitive
prices. Happily, this is a business ethic
that Structure-flex Limited of Melton Constable
in North Norfolk has embraced for many years,
and to satisfy demand for its packaging solutions,
the company has recently sourced an FIBC supplier
in China.
Structure-flex has a reputation for the development
and manufacture of FIBC Bulk Bags, and is a recognised
leading supplier to many market segments, including
major ‘Blue Chip’ companies.
The FIBCs are used for the transport and storage
of a full range of materials from the food and
drinks industries, pharmaceutical and chemical
industries and waste by-products.
Terry Scannell, Supply Chain Manager at Structure-flex
comments: “The FIBC market is a fast
moving industry, where the demands of the consumer
dictate short lead times and J.I.T. deliveries
of the highest quality products at ultra-competitive
prices. In the past, Structure-flex has
manufactured products from its own facility; however,
as a result of the rapid increase in global trading
opportunities and the growth of customers’
own markets, the industry has seen the development
of new overseas supply routes which can offer
products of the highest quality whilst maintaining
excellent value for money.”
Structure-flex has fully embraced these changes.
It has devoted a great deal of time and resources
to ensure that its position as a market leader
is maintained, and that, through working with
supply partners, it can continue to offer the
highest standard of service to its customers.
To this end, the Purchasing Department has
undertaken a full review of all key potential
FIBC suppliers.
“It became clear that there is a strong
core of experienced manufacturers based in the
highly industrialised area around Shanghai in
China which would be worth a visit,” Terry
goes on to explain. “The fact-finding
mission proved to be a worthwhile exercise, underlining
the vast differences between suppliers and the
importance of applying our own quality audit /
vendor rating system when choosing which company
to work with.
“However, as a result of this process we
found three potential supply partners that were
able to meet our stringent criteria, which includes
the ability to design and manufacture to the highest
quality specifications, to be able to work to
tight deadlines with regard to shipping requirements,
and with excellent technical, commercial and communications
strengths within their work force.”
Structure-flex has now received its first production
runs from its preferred Chinese supplier, which
have achieved all its objectives.
Matt Doughty, Head of Sales and Marketing at
Structure-flex, is very satisfied with this most
recent supply partnership, saying: “The
Chinese supply option opens up our potential marketing
place, providing an AIB food grade approved source
that enables Structure-flex to compete in the
high volume, low cost segment. FIBCs from
China will complement products from our existing
European suppliers. We are now able to offer
a cost-effective, high quality product with the
reassurance of recognised quality standards, and
still provide the same degree of technical and
logistical support. The supplier review
/ vendor rating programme served us well in China,
and will continue to be used by the purchasing
team to monitor the performance and quality of
our FIBC partners. Our customers can have
confidence in our product range wherever they
are sourced.”
Prefilled
WFI Syringe Provides a High-Quality Solution for
Drug Reconstitution
Ravensburg,
May 8, 2009 - West (NYSE: WST), the world’s
premier manufacturer of components and systems for
injectable drug delivery, and Vetter, a worldwide
leading independent specialist in the contract manufacturing
of prefilled application systems, have introduced
a ready-to-use, WFI prefilled syringe for reconstituting
lyophilized drug products.
“The Vetter/West WFI syringe combines the
best of pharmaceutical components in a drug administration
system that we believe customers will embrace,”
said Mike Schaefers, Vice President, Marketing,
Europe, West. “This system can be applied
to our customers’ high-value pharmaceutical
and biopharmaceutical drug products.”
“This system unites two of the world’s
leaders in drug administration systems and pharmaceutical
processing,” said Oskar Gold, Vice President,
Key Account Management, Vetter. “We are pleased
that we can offer customers a world-class prefilled
syringe system.”
The syringe features a plunger with West’s
FluroTec® barrier film and Vetter’s V-OVS®
tamper-evident closure, which includes a West tip
cap. The film, developed by West’s partner,
Daikyo Seiko, Ltd., provides an effective barrier
against organic and inorganic extractables, which
helps maintain the purity of the diluent.
The V-OVS® closure system is designed to give
a prefilled syringe system effective protection
features. It consists of a tip cap, a Vetter Luer
Lock and a tamper-evident seal. The components are
pre-assembled as a single part, which is mounted
on the syringe barrel with a Luer-cone and Luer-groove.
The integrity of the syringe system is maintained
if the seal has not been broken.
The syringes are available with fill volumes between
0.5mL and 3.0mL. The glass syringe barrels are treated
with baked silicone for lubricity and are 100 percent
visually inspected to provide highest quality levels.
Customers will have packaging options, including
individual blister packaging.
Vetter fills and terminally sterilizes the syringe
at its facility in Langenargen, Germany. The syringes
are supplied with regulatory documentation to meet
requirements of markets in Europe, Japan, North
America and numerous other countries.
About West
West is a global manufacturer of components and
systems for injectable drug delivery, including
stoppers and seals for vials, and closures and
disposable components used in syringe, IV and
blood collection systems. The Company also provides
products with application to the personal care,
food and beverage markets. Headquartered in Lionville,
Pennsylvania, West supports its partners and customers
from 50 locations throughout North America, South
America, Europe, Mexico, Japan, Asia and Australia.
For more information, visit West at www.westpharma.com.
About Vetter
Vetter is an independent international specialist
in the production of aseptically pre-filled injection
systems, cartridges and vials. Based in Ravensburg,
Germany, Vetter also produces its own injection
systems, such as the Vetter Lyo-Ject® dual-chamber
syringe. With about 1,900 employees worldwide,
Vetter holds about 140 patents and has longstanding
experience in handling client products and processes
approved by the FDA, EMEA and other authorities.
FluroTec® is a registered
trademark of West Pharmaceutical Services, Inc.
in the United States and other jurisdictions.
FluroTec technology is licensed from Daikyo Seiko,
Ltd.
Vetter and V-OVS® are registered trademarks
of Vetter Pharma-Fertigung GmbH& Co.KG in
Germany, the United States and other jurisdictions.
MixJect® is a registered trademark of Medimop
Medical Projects Inc.
Pfeiffer
invests EUR 12 million in new logistics and technology
centres
Pfeiffer
invests EUR 12 million in new logistics and technology
centres - Extensive pharmaceutical division
building programme in Germany focuses on current
and future customer needs
(Radolfzell, Germany, 22 April 2009) -
Pfeiffer, a leading manufacturer of pharmaceutical
pumps, is investing EUR 12 million in a new building
project at its main manufacturing plant in Eigeltingen,
Germany. A logistics centre and a new technical
centre, covering a combined floor area of over 6,500
m², will both go into full operation in 2009.
The logistics centre incorporates high bay racking,
dedicated delivery and dispatch areas, plus a state-of-the-art
packaging facility. In the technical centre,
tools will be built, tested, maintained and repaired
by the on-site experts. The new premises enable
optimal process efficiency, allowing Pfeiffer to
meet customer needs in an increasingly competitive,
highly regulated market environment.
Multiple benefits The increased capacity and operational efficiency
of the new logistics centre, in use since January
2009, translates directly into measurable benefits
for staff and customers. Its spacious architecture,
integrating maximum daylight, provides a modern,
ecologically responsible working environment. Excellent
hygienic conditions, including plastic palettes,
the total elimination of cardboard, and air screens
preventing contamination from the integrated loading
bays, bring clear advantages to customers. The new
centre also includes an incoming laboratory, where
all materials delivered are checked in accordance
with the stringent Pfeiffer quality standards. This
completes the quality circle, ensuring optimal efficiency
from start to finish of the logistics chain. Drivers
collecting goods from the plant also have automatic
access to self-contained showering and rest facilities
adjacent to the office area for the dispatch administration
services. The technical centre will go into operation
in August 2009 with its industrialisation and tooling
services covering an area across 3,375 m² on
two floors.
Building the future Thomas Klofac, President of the Pfeiffer
Pharma Division, explains that the current investment
programme is geared to meeting growing demand, particularly
for the new Pfeiffer ophthalmic products, electronic
dispensing technology and systems for preservative-free
substances. Extending the facilities in Eigeltingen
also reconfirms the company’s proven commitment
to German engineering. He concludes, “Pfeiffer
is committed to maintaining long-term relationships
with employees, suppliers and customers. Our new
facilities are proof of this commitment and our
key to being able to react to market needs today
and tomorrow.”
Pfeiffer
at a glance
The company Ing. Erich Pfeiffer GmbH was founded
in 1947. Today the company is one of the world’s
leading pharmaceutical pump manufacturers and has
600 employees. The company headquarters are in Radolfzell
in Southern Germany with the main production facilities
in nearby Eigeltingen. Pfeiffer also is represented
across all five continents via an extensive network
of sales offices. The Pfeiffer pharmaceutical product
portfolio encompasses a wide range of dispensing
systems for drug administration via the nasal, oral,
dermal and ophthalmic routes. www.pfeiffer-group.com
Facts and Figures
– New Facilities
Total
financial investment
EUR
12 million
Project
start date – logistics centre
February
2008
Project
completion date – logistics centre
January
2009
Project
start date – technical centre
August
2008
Project
completion date – technical centre
End
of July 2009
Total
usable surface area
6510
m²
Surface
area – logistics centre
3135
m²
Surface
area – technical centre
3375
m²
Vetter
launches Project Management Quality Assurance Program
Vetter
launches Project Management Quality Assurance Program
Employees to receive IPMA certification
Ravensburg, April 7, 2009 – With a new state-of-the-art
project management program, Vetter will help pharmaceutical
and biotech companies to better control the quality
and costs of their pre-filled injectable product
manufacturing processes. As a specialist in the
aseptic filling of syringes, cartridges and vials,
Vetter has launched an extensive quality assurance
program for its project managers, which ultimately
should lead to their certification by the International
Project Management Association (IPMA).
Vetter expects the program to further boost its
efficiency. In today’s competitive international
markets, pharmaceutical and biotechnology companies
receive a boost from smooth processes and short
throughput times, which help get products to market
more quickly.
“Before commercial manufacturing ever begins,
we spend years working together with the customer
on packaging and production processes,” said
Jochen Alberstetter, Vice President of Project Management
for Vetter. First, the basic tools of project management
were introduced in the entire company. “By
undergoing an IPMA audit, we can now help our clients
benefit from the highest-quality project management
available.”
The IPMA has set up a rigorous process to test project
managers and ensure they are prepared for the tasks
that lie ahead. Each participant in the certification
program must have at least three years of experience
in project management, plus two years of practical
work leading a project.
The candidate is assessed on a wide variety of criteria,
including the ability to plan, control, communicate
and solve problems. Certification then is awarded
to those who demonstrate deep organizational knowledge,
as well as leadership qualities.
IPMA is a world leading project management organization
that currently represents 45 national project management
associations and over 55,000 members on the international
level. The IPMA has a strong presence in Europe
as well as North and South America, Asia and Africa.
Because of the proximity to Austria, the IPMA certification
was carried out by Project Management Austria (PMA).
For
more information contact
Vetter Pharma International GmbH
Oskar Gold
Eywiesenstrasse 5
88212 Ravensburg
Germany
phone: +49-(0)751-3700 - 0
fax: +49-(0)751-3700 - 40 00
e-mail: info@vetter-pharma.com www.vetter-pharma.com
About Vetter:
Vetter is an independent international specialist
in the aseptic filling of syringes, cartridges
and vials. Based in Ravensburg, Germany, Vetter
also produces its own injection systems, such
as the Vetter Lyo-Ject® dual-chamber syringe.
The company employs about 1,900 people world-wide
and holds nearly 140 patents. Vetter boasts longstanding
experience in handling client products and processes
approved by the FDA, the EMEA and other authorities.
Vetter Development Service provides support for
its pharmaceutical and biotech clients in the
early stages of development, from clinical phases
and regulatory approval to worldwide product launch.
Vetter Commercial Manufacturing handles the entire
production process, from compounding and aseptic
filling to the final packaging of a product. Vetter
Solutions’ patented application systems
enable clients to compete more effectively throughout
the world.
As
GPCR Space Becomes More Crowded, Drug Makers Show
Affinity for Non-traditional GPCR Binding Sites
As GPCR Space Becomes More
Crowded, Drug Makers Show Affinity for Non-traditional
GPCR Binding SitesNew service from Millipore
reveals selectivity of novel allosteric drugs
Billerica, Mass. – April
5, 2009 – Millipore
Corporation
(NYSE: MIL) today announced the release
of their AllostericProfiler™
service for use by researchers developing new
drugs using G-protein coupled receptors (GPCRs),
an important class of proteins for the treatment
of multiple diseases and also drug side-effects.
Although 40% of all marketed drugs
are targeted to G-protein coupled receptors (GPCRs),
the similarity of GPCR binding sites coupled with
saturated intellectual property around this chemical
space have hampered GPCR drug discovery efforts.
Increasingly, drug makers are instead focusing
on novel allosteric GPCR sites to open up new
chemical spaces. (Allosteric GPCR binding sites
modulate native ligand binding sites and are potentially
more specific.)
Facilitating the research of allosteric
sites, Millipore’s AllostericProfiler™
service is the first to provide drug developers
with cell-based assays to evaluate the functional
selectivity of drugs against GPCRs.
“Allosteric modulators of
GPCRs provide exciting new opportunities to discover
and develop selective activators and inhibitors
of GPCRs that have proven intractable when targeting
orthosteric sites,” said Dr. Jeffrey Conn,
Director of the Vanderbilt Program in Drug Discovery
within the Department of Pharmacology at the Vanderbilt
University Medical Center. “Our new understanding
of allosteric modulation of GPCRs forces a shift
in our thinking about approaches to panel screening
for selectivity of novel agents and suggests that
it is critical to employ functional panel screens
of GPCR selectivity rather than relying exclusively
on radioligand binding,” Conn added.
Millipore’s AllostericProfiler
service allows researchers to screen the selectivity
of their allosteric compounds for over 150 different
GPCRs. Millipore can also provide custom services
(AllostericScreener™ service) to help researchers
identify new positive allosteric modulators for
a GPCR target of interest.
By using a unique two-step addition
protocol, the AllostericProfiler service detects
both orthosteric compounds (which bind the native
site) as well as allosteric modulators. First,
the test compound is added to cells stably expressing
a GPCR to determine whether the compound has agonist
activity. Second, a dose response of a reference
agonist, typically the native ligand, is added
in the presence or absence of the test compound
to compare how the test compound changes the reference
agonist’s potency and efficacy. These changes
can reveal activities ranging from positive to
negative allosteric modulation.
“The search for druggable
allosteric sites on GPCRs has begun in earnest,”
observed Blaine Armbruster, Millipore Product
Manager for GPCR Drug Discovery. “The therapeutics
Cinacalcet (for hyperparathyroidism) and Maraviroc
(for HIV) are both allosteric GPCR modulators
and more GPCR-modulating drugs are in development.”
The AllostericProfiler service
is the latest addition to Millipore’s GPCRProfiler®
service offering, which was launched by Millipore
in 2006 as the first outsourced cell-based functional
assay service for GPCR profiling using Millipore’s
robust ChemiScreen™ GPCR cell lines.
About Millipore: Millipore (NYSE: MIL) is a Life Science
leader providing cutting-edge technologies, tools,
and services for bioscience research and biopharmaceutical
manufacturing. As a strategic partner, we collaborate
with customers to confront the world’s challenging
human health issues. From research to development
to production, our scientific expertise and innovative
solutions help customers tackle their most complex
problems and achieve their goals. Millipore Corporation
is an S&P 500 company with more than 5,900
employees worldwide. For more information, please
contact Millipore Tech Service at 1-800-548-7853
or 951-676-8080 or visit www.millipore.com.
Millipore Media Contact: Greg Hoff, Media Relations, Bioscience
Division
978-762-5170 or greg_hoff@millipore.com
Millipore and GPCRProfiler are
registered trademarks and the “M”
logo. AllostericProfiler, AllostericScreener,
ChemiScreen, and ADVANCING LIFE SCIENCE TOGETHER
are trademarks of Millipore Corporation.
Millipore
Introduces New Tools for Vascular Biology Research
Millipore
Introduces New Tools for Vascular Biology Research New line of cells and optimized media
improve growth and morphology of in vitro models
Billerica, Mass. – March 25, 2009 - Millipore
Corporation (NYSE: MIL) today announced the
release of EndoGRO™
products for vascular research, including human
umbilical vein endothelial cells (HUVEC) and advanced
media formulations for endothelial cell culture.
Endothelial cells play a key role in a range of biological
processes. In vitro cell models are commonly
used for physiological and pharmacological investigations
of angiogenesis, clotting, and inflammation, as
well as arteriosclerosis and vascular disorders.
EndoGRO advanced media products include four uniquely
optimized formulations for large vessel and microvascular
endothelial cells, as well as low-passage HUVEC.
EndoGRO media formulations have lower serum concentrations
than standard endothelial cell culture media, yet
have been shown to support endothelial cell growth
rates that exceed other commercially available serum-containing
media, while maintaining excellent cell morphology.
In addition, the media have no phenol red or antimicrobials,
which can cause cell stress and mask natural biological
processes.
EndoGRO human umbilical vein endothelial cells are
cultured for only one passage before cryopreservation
to ensure the highest viability and culture life.
Growth of these cells is enhanced by the use of
EndoGRO media. EndoGRO cells and media are part
of Millipore’s expanding selection of specialty
cell culture tools. More information is available
at www.millipore.com/cellbiology.
About Millipore Millipore (NYSE: MIL) is a Life Science
leader providing cutting-edge technologies, tools,
and services for bioscience research and biopharmaceutical
manufacturing. As a strategic partner, we collaborate
with customers to confront the world’s challenging
human health issues. From research to development
to production, our scientific expertise and innovative
solutions help customers tackle their most complex
problems and achieve their goals. Millipore Corporation
is an S&P 500 company with more than 5,900 employees
worldwide. For more information, please contact
Millipore Tech Service at 1-800-548-7853 or 951-676-8080
or visit www.millipore.com.
ADVANCING LIFE SCIENCE TOGETHERTM
Research. Development. Production.
Millipore Media Contact Greg Hoff
Media Relations Bioscience Division978-762-5170 greg_hoff@millipore.com
Vetter
Pharma Fertigung GmbH & Co. KG Launches New
Subsidiary
Vetter
Pharma Fertigung GmbH & Co. KG Launches New
Subsidiary
Vetter Pharma International GmbH (VPI) will Focus
on Global Sales, Service
Ravensburg, Germany – Vetter Pharma-Fertigung
GmbH & Co. KG (VPF) today announced the formation
of a new subsidiary, Vetter Pharma International
GmbH (VPI). With a scheduled launch date of April
1, 2009, VPI will be responsible for all Vetter
sales, marketing and customer service activities
on a worldwide level.
Peter Soelkner has been named Managing Director,
and Oskar Gold will serve as Vice President of the
new entity. Headquarters will be in Ravensburg,
Germany, and Vetter Pharma International USA Inc.
will be located in Yardley, PA.
“The formation of VPI allows us to better
position ourselves as a worldwide leader in pre-filled
aseptic injection solutions,” Soelkner said.
“By creating an entity that focuses exclusively
on sales, marketing and customer service on a global
level, Vetter will move significantly closer to
the international market and can build even stronger
relationships with our clients and prospects throughout
the world.”
VPF, which previously has managed all of Vetter’s
sales, services and manufacturing activities under
a single corporate umbrella, will now focus exclusively
on the company’s manufacturing and pharmaceutical
operations. VPF will continue to be a strong partner
for pharmaceutical and biotech companies, providing
high quality pharmaceutical services that support
the supply chain of aseptically pre-filled injectable
products, from clinical development to market launch
to ongoing delivery worldwide, Soelkner said.
“By realigning our resources to empower each
entity’s core competencies, both VPI and VPF
alike can be major catalysts in Vetter’s continued
growth and expansion in the years to come—no
matter how much the industry may change,”
he added.
For
more information contact:
Vetter Pharma-Fertigung GmbH &
Co. KG
Oskar Gold
Schuetzenstrasse 87
88212 Ravensburg
Germany
Phone: +49-(0)751-3700 - 0
Fax: +49-(0)751-3700 - 40 00
E-mail: info@vetter-pharma.com www.vetter-pharma.com
About Vetter Pharma-Fertigung GmbH &
Co. KG:
Vetter is an independent international specialist
in the aseptic filling of syringes, cartridges and
vials. Based in Ravensburg, Germany, Vetter also
produces its own injection systems, such as the
Vetter Lyo-Ject® dual-chamber syringe. With
about 1,900 employees worldwide, Vetter holds nearly
140 patents and has longstanding experience in handling
client products and processes approved by the FDA,
the EMEA and other authorities. In 2007, the company
also received the go-ahead as a foreign manufacturer
for the Japanese pharmaceutical market from Japan’s
Ministry for Health, Labor and Welfare. Additionally,
Vetter has received two awards for its new facility
Ravensburg Vetter South (RVS): The Facility of the
Year Award 2007 (Process Innovation category) and
the European Outsourcing Award 2007 (Most Improved
Process/Plant/Facility category).
Vetter Development Service provides support for
its pharmaceutical and biotech clients in the early
stages of development, from clinical phases and
regulatory approval to worldwide product launch.
Vetter Commercial Manufacturing handles the entire
production process, from compounding and aseptic
filling to the final packaging of a product. Vetter
Solutions’ patented application systems enable
clients to compete more effectively throughout the
world.
Almac
win ‘Exporter of the Year’ in economic
awards
Almac win ‘Exporter
of the Year’ in economic awards
The Almac Group, headquartered
in Craigavon Northern Ireland, with further sites
across the UK and USA, is celebrating success
after being named ‘Exporter of the Year’
by Northern Ireland’s economic development
agency, Invest Northern Ireland.
The ‘Exporter of the Year’ award recognises
outstanding export achievement and growth of a
local business which have been exporting for over
four years. It was one of five awards presented
to local businesses as part of the Invest NI Innovation
& Export Awards.
The achievement comes on the back of a successful
2008 for the group with export sales generating
over 70% of the company turnover.
Almac are a major contributor to the Northern
Ireland economy and are becoming increasingly
important as it moves towards a high-value knowledge-based
economy with strong potential for further development
in the Pharma and Biotech sectors.
Almac’s Chief Executive Officer Alan Armstrong
expressed pride in the recognition and said 2009
is going to be an exciting year for the company.
Pictured
L-R are Richard Ennis, Ulster Bank (awards sponsor),
Martin Lamb, Almac and Rotha Johnston, Invest
NI.
“As a Northern Ireland based company doing
business with clients right across the globe,
we have always understood the importance of developing
existing export markets as well as exploring new
export opportunities.
“This award from Invest NI is testament
to the innovation of our company and the ingenuity
of those working right across the Almac Group.
For many years we have recognised the significance
of building a balanced client portfolio right
across the sector and this strategy is proving
all the more important during the current downturn.
We continue to recruit and have a positive outlook
for the future. I would like to take this opportunity
to offer my congratulations to all those working
at Almac who make our success possible."
About Almac
The Almac Group comprises five closely integrated
divisions offering a broad range of services from
R&D, translational genomic services, API manufacture,
product development, clinical trial supply and
technology (IVRS/EDC), to commercial-scale manufacture.
Almac provides services to over 600 companies
including all the world leaders in the pharmaceutical
and biotech sectors.
The company has almost 2,200 employees and is
headquartered in Craigavon, Northern Ireland.
US operations are based in Pennsylvania, North
Carolina and California. Construction of the company’s
new $100m North American Headquarters started
in July 08 and is expected to be completed 2010.
DHL
secures £7m contract with Guy’s and
St Thomas’ hospitals
DHL
secures £7m contract with Guy’s and
St Thomas’ hospitals
London, UK – 16th February 2009:
DHL Exel Supply Chain, the world’s leading
logistics services provider, has been awarded a
five year hospital logistics contract with Guy’s
and St Thomas’ Foundation Trust (GSTFT) -
comprising two of London’s most well known
teaching hospitals.
DHL will provide off-site cross docking of products
from multiple suppliers, and - for medical surgical
consumables - replenish the hospitals new Smart
Store™ automated stock management systems.
The solution will also control supplies held in
operating theatres and wards, resulting in a leaner
supply chain.
Glen McCracken, Business Manager, Hospital Managed
Inventory Solutions, DHL Exel Supply Chain, said:
“DHL is keen to deliver added value through
dedicated operational support and unrivalled expertise
in inventory management and lean hospital supply
chains. Integral to the solution will be the use
of DHL’s dedicated off-site facility at Park
Royal which has ten years experience in supporting
hospitals.”
The contract was awarded, following a competitive
tender, on the basis of DHL’s experience and
expertise in hospital logistics and its tailored,
cost-effective solution for the Trust.
David Lawson, Director of Procurement, GSTFT, said:
“The impressive track record of DHL’s
hospital logistics hub at Park Royal was a key deciding
factor during the selection process. The contract
forms a key part of a wider strategy to fundamentally
redesign the hospitals’ supply chain. The
service will improve the reliability of the supply
chain by helping the hospitals to proactively performance
manage its suppliers.”
The contract will also drive the development of
a fully integrated and multi-skilled internal logistics
team - a central function in the success of the
project.
“Our solution provides a dedicated team of
people that will oversee replenishment, quality
assurance and support functions. DHL understands
the importance of people, both customer and staff,
in influencing the success of the project which
is why a strong emphasis on communication has been
factored into the solution,” added Glen McCracken.
DHL
DHL is the global market leader of the international
express and logistics industry, specializing in
providing innovative and customized solutions
from a single source.DHL offers expertise in express,
air and ocean freight, overland transport, contract
logistic solutions as well as international mail
services, combined with worldwide coverage and
an in-depth understanding of local markets. DHL's
international network links more than 220 countries
and territories worldwide. Some 300,000 employees
are dedicated to providing fast and reliable services
that exceed customers' expectations.
DHL is a Deutsche Post World Net brand. The group
generated revenues of more than 63 bn euros in
2007.
Dr.
Paul Lohmann® adds Fermentation Grade Calcium
Formate to its portfolio
Dr.
Paul Lohmann® adds Fermentation Grade Calcium
Formate to its portfolio
Dr. Paul Lohmann® has just added a new Calcium
Formate grade to its product portfolio, especially
designed for the usage in fermentation purposes.
Usually Calcium Formate is a by-product to Pentaerythritol
(Penta), and is mainly used in the feed market and
in the construction industry, where very basic qualities
are applied.
For applications in the pharma sector but also for
the fermentation of enzymes, a different quality
is required. This kind of product is not used from
the above side stream, but is processed on-purpose
by Dr. Paul Lohmann® from the raw materials
in order to ensure the required quality level.
Dr. Paul Lohmann® is the world’s leading
provider of specialty mineral salts to the nutrition,
dietary supplement, pharmaceutical, cosmetic and
technical industries. Over 120 years of manufacturing
experience – combined with innovation and
flexibility – enables us to respond rapidly
to the changing market needs. We offer the broadest
available portfolio of mineral salts: more than
350 in about 4000 qualities, designed to provide
optimum performance across a wide range of applications.
Today we add one quality more: Fermentation Grade
Calcium Formate.
Dr. Paul Lohmann GmbH KG
Contact:
Dr. Paul Lohmann GmbH KG
Hauptstrasse 2
31860 Emmerthal
Germany
T: +49 5155 630
F: +49 5155 63345 sales@lohmann4minerals.com
DHL
expands healthcare offer with contract packing and
kitting
DHL expands healthcare offer with contract
packing and kitting
DHL Exel Supply Chain UK to launch extended
solution nationally
London, UK – 22
January 2009: DHL Exel Supply Chain,
the world’s leading logistics services provider,
today announced the continued expansion of its
contract cGMP (Good Manufacturing Practice Compliance)
packing and kitting offering, which will now be
available as a stand-alone service within its
healthcare warehouses and distribution centers
across the UK.
The solution has been offered for the past 12
years for customers seeking consolidated warehousing
and packaging activities, providing improved efficiency
and reduced waste. Due to increased capacity,
DHL is now able to offer hand-based assembly,
rework and co-packing as a stand-alone service
to new and existing customers, covering pharmaceuticals,
drug delivery systems, medical devices, surgical
consumables and sample pack preparation.
The solution includes secondary packaging, reworking,
kitting and late customization to market or customer
specific requirements.
DHL is licensed by the Medicines and Healthcare
Products Regulatory Agency to conduct a range
of cGMP packaging services. Licenses include
commercial and clinical trial materials. DHL also
has a number of Qualified Persons to release products
following packaging activities.
Jonathan Blamey, Vice President Product Development
Healthcare, DHL Exel Supply Chain EMEA, said:
“At DHL, we pride ourselves on understanding
our customers and offering tailored solutions
according to their needs. This solution enhances
our current healthcare offering, allowing more
customers to utilize assembly and packaging, combined
with storage and distribution, to deliver an integrated
supply chain. This provides increased flexibility
and responsiveness to market requirements.”
Caroline Fox, Technical Services Manager Healthcare,
DHL Exel Supply Chain UK, said: “The solution
offers our customers a cost-effective and consolidated
supply chain that is backed by the expertise and
knowledge of the world’s leading logistics
services provider. For many customers,
having a complete packaging and distribution service
under one roof means reduced operating costs,
with greater supply chain control and visibility.”
DHL Healthcare’s contract packing and kitting
solution has already achieved success in various
countries throughout Europe, including The Netherlands,
Belgium, Italy and Turkey.
DHL
DHL is the global market leader of the international
express and logistics industry, specializing in
providing innovative and customized solutions
from a single source.
DHL offers expertise in express, air and ocean
freight, overland transport, contract logistic
solutions as well as international mail services,
combined with worldwide coverage and an in-depth
understanding of local markets. DHL's international
network links more than 220 countries and territories
worldwide. Some 300,000 employees are dedicated
to providing fast and reliable services that exceed
customers' expectations.
DHL is a Deutsche Post World Net brand. The group
generated revenues of more than 63 bn euros in
2007.
Almac Clinical Services now employs 1100
worldwide as it reaches its twentieth year
Almac Clinical Services, one of
the key divisions at the Almac Group, has this
month reached its twentieth year of operation.
The Clinical Services division was founded in
1988 and has grown to become the largest and one
of the most successful parts of the Almac family.
Originally operating with two employees
in one location in Craigavon, the company now
employs 1100 skilled individuals across three
main operational centres – Craigavon (UK),
Audubon (PA) and Durham (NC) in the US.
Almac Clinical Services has enjoyed
exceptional year-on-year growth and continues
to out-perform in the clinical supply marketplace
in what has become an ever more challenging and
competitive environment globally. The ongoing
success has been built on a solid platform of
providing service excellence to all clients irrespective
of size, with Almac’s highly skilled and
dedicated staff working within a quality ethos
across all sites.
As Almac Clinical Services enters
its third decade of operations, the company is
now firmly established as a market leader in provision
of world-class clinical services. Almac has recently
announced further expansion with a new $110m North
American Headquarters in the US, which will create
hundreds of additional new jobs in Pennsylvania
as well as further opportunities for existing
staff.
Commenting on this milestone, Almac
Clinical Services MD Dr Robert Dunlop said: “When
we began trading as Clinical Trial Services, we
competed in the market by offering all of our
clients exceptional customer service. Although
the service we provide has been complemented as
technological and other advancements are made,
that core commitment to customer services remains
as strong as it was twenty years ago.
“Many of the staff who founded
and contributed to the progress of our company
are still with us today and have helped ensure
Almac Clinical Services continues to occupy the
market leading position it acquired many years
ago.
“We congratulate all of those
who have worked here over the past twenty years,
both our dedicated staff and faithful clients
alike. I am confident that over the next twenty
years and beyond we will continue to develop the
services that our market deserves and that our
dedication to service will remain as strong as
ever,” he added.
Contact:
Carl Whyte
Stakeholder Communications
+44 (0)28 9033 9949
About Almac
The Almac Group comprises five
closely integrated divisions offering a broad
range of services from R&D, translational
genomic services, API manufacture, product development,
clinical trial supply and technology (IVRS/EDC),
to commercial-scale manufacture. Almac provides
services to over 600 companies including all the
world leaders in the pharmaceutical and biotech
sectors.
The company has almost 2,200 employees
and is headquartered in Craigavon, Northern Ireland.
US operations are based in Pennsylvania, North
Carolina and California. Construction of the company's
new $100m North American Headquarters started
in July 08 and is expected to be completed 2010.
BMG
LABTECH is proud to announce the launch
of the next generation HTS microplate reader -
PHERAstar FS
BMG LABTECH Launches the New PHERAstar
FS – The Next Generation HTS Microplate
Reader.
BMG LABTECH, the world leader in microplate reader
technology, launches the new top of the line HTS
plate reader, the PHERAstar FS. It is
based on the successful PHERAstar Plus
and incorporates the following new features: Tandem
Technology, which uses highly sensitive, Filter
based detection in all modes and an industry first,
ultra-fast UV/Vis Spectrometer; on-board reagent
injectors for precise kinetic measurements; advanced
bottom reading for cell-based assays; and a dedicated
UV-laser for all TR-FRET based assays. To learn
more about this exciting new reader visit us at
booth 456 at Lab Automation 2009.
The PHERAstar FS performs all of the
leading non-radioactive detection technologies,
including fluorescence intensity, fluorescence
polarization, time-resolved fluorescence / TR-FRET,
laser-based AlphaScreenÒ, luminescence
/ BRET, and UV/Vis full spectrum absorbance. The
PHERAstar FS achieves advanced performance
in all reading modes, including HTRFÒ /
TR-FRET, through an innovative lens-based optical
system. This system is combined with a unique
technology that ensures the optimal use of different
mode-specific PMTs and excitation sources. In
addition, BMG LABTECH readers are the only ones
on the market that can capture TR-FRET decay curves
in real-time for assay optimization. For HTS automation
purposes, the PHERAstar FS is easily
integrated into numerous robotic platforms or
it can be equipped with BMG LABTECH's 50 plate
Stacker II.
The PHERAstar FS is driven by BMG LABTECH’s
well-known Reader Control software and data evaluation
is performed by BMG’s exclusive Microplate
Analysis and Reduction Software, MARS. The MARS
Wizard creates an easy step-by-step calculation
of a standard curve and the MARS Template Manager
is an excellent tool for building complex data
processing protocols. Thus, user-defined data
analysis is one mouse click away. Enhanced robotic
integration capabilities, digital signature, and
the 21 CFR part 11 compliance of MARS complete
this software package, making the PHERAstar FS
the HTS reader of choice. Information about all
BMG LABTECH´s microplate readers can be
found on the company’s website: www.bmglabtech.com
AlphaScreen is a registered trademark of PerkinElmer,
Inc.
HTRF is a registered trademark of Cisbio International.
Hovione
buys Pfizer’s Loughbeg API Facility
Hovione
buys Pfizer’s Loughbeg API Facility
Loures, Portugal, December 11th, 2008 - Hovione
announced today that it has agreed with Pfizer
to acquire their Loughbeg Active Pharmaceutical
Ingredients (API) site in Ireland. This site manufactures
intermediates for Lipitor active pharmaceutical
ingredient.
The site has had a number of owners starting
in 1984 with Angus Fine Chemicals, then Hickson
& Welch, Warner Lambert, Pfizer and now Hovione.
Over the last 10 years Pfizer has invested several
hundred million dollars in plant and equipment
there, making it a modern, well equipped site,
meeting the highest standards in the industry.
The deal is scheduled to be completed by early
April 2009. Hovione Cork will employ 70-80
staff and will, over the next 24 months be
transferring products from its Loures, Portugal
site and validating processes for new compounds
in expectation of drug approval. The terms
of the transaction were not disclosed but Hovione
will continue to provide manufacturing services
for Pfizer.
"We made clinical trial materials for over
40 drug candidates last year. We have been
investing heavily in R&D for over 6 years
and now have a strong development pipe-line but
have not invested in manufacturing assets since
2001, so it was time that we expanded our
manufacturing capacity. This site offers
everything that our Customers might want: large
scale capacity, the highest standards, in a
location where tax benefits are available to them
and a well trained, innovative work-force"
said Miguel Calado, CFO. The plant adds
427m3 of capacity to Hovione's 810m3 - of which
400m3 are in Portugal and the remainder in China.
The plant is multi-purpose and is able to address
a large number of specialized chemistries such
as hydrogenation and low temperature chemistry.
The Cork site also provides Hovione with a new, €70m
capability to produce spray-dried formulations.
Hovione is the world's leading provider of GMP
spray-drying services covering every scale
(lab, pilot and several intermediate production
scales) and is able to provide R&D support
and commercial manufacturing.
At a time when most fine chemical producers are
investing in Asia, Hovione is turning to Ireland.
Cork has the highest concentration of API production
anywhere in the world, with a vast and deep talent
pool, with an excellent cGMP record with the health
authorities since the mid-nineties. These
sites belong to Large Pharma, companies that are
now embracing outsourcing as a key part of their
long-term manufacturing strategy. Hovione
believes that having the right kind of capacity
in Cork will help it better serve its Innovator
customers when it comes to making APIs for their
new product introductions. "We have
been manufacturing in China for over 25 years
- we know very well what China can do for the
Pharma industry, but we also know what it can't
do - and it is for those reasons that we are now
in Cork" said Guy Villax, Chief Executive,
"The Cork site, the New Jersey Technology
Transfer Centre, Loures in Portugal and Taizhou
and Macau in China now provide Hovione with the
right range of capabilities in the correct geographies
- every site meets FDA requirements for APIs but
every site is suited to a different and well defined
mission" he added.
Pharma manufacturing needs to become lean and
cost-effective and this is always a challenge.
The outsourcing business model gives manufacturers
a head start, as contractors can provide their
services to any Innovator company for any product
and thus benefit from lower risk, better utilization
of facilities and scale. In addition the
contractor can select those compounds that have
a good fit with its plant's technical capabilities,
in turn the pharma company can avoid the expensive
plant modifications often required to manufacture
these compounds. It is this ability to produce
for anyone that will contribute to making compounds
fast and less expensively to the benefit of all
stake-holders. However achieving this goal
requires the ability to produce multiple small
production campaigns -many simultaneously-, the
skill to do rapid change-overs with validated
cleaning, multi-purpose equipment design and lay-out
that operate within a quality system specially
designed for high levels of compliance yet of
simple execution. This is what Hovione will
be able to bring to the Cork site. "The
combination of Hovione's 50 years of experience
in API manufacture and contract manufacturing
and the capabilities of the existing plant and compliance
tradition of the Cork colleagues are a winning
combination", said Noé Carreira, VP
Manufacturing.
Hovione is
an international group specializing in the development
and compliant manufacture of active pharmaceutical
ingredients, serving exclusively the pharmaceutical
industry. With a
50-year track record, Hovione offers advanced
technologies as well as APIs for all drug delivery
systems, from oral to injectable and from inhalation
to topical applications. With
FDA inspected plants in Europe, the Far East and
the US, Hovione is committed to the highest levels
of service and quality. Specializing
in complex chemistry and in particle engineering,
Hovione offers all services related to the development,
manufacture and pre-formulation of both new chemical
entities (NCEs) and existing APIs for off-patent
products.
For further information about Hovione, please
visit the Hovione site at www.hovione.com
or
contact Corporate Communications
(Isabel Pina,
+ 351 21 982 9362,
e-mail: hello@hovione.com).
DPL
Press Release Week 39 / 2008
Dr. Paul Lohmann®
announces the opening of the companies new FEA (research,
development and application) laboratory in June
2008 at their Emmerthal site in Germany. The FEA
labs are dedicated to support customized development
programs for the companies customers in Pharma,
Food and other application areas.
With the new laboratory facilities, Dr. Paul Lohmann®
quintupled its lab capacity. The company is now
able to
manage versatile research and development tasks
according to customer inquiries. Furthermore, Dr.
Paul Lohmann® can offer its customers a cooperative
development in the application technology labs on
site in Emmerthal. Particularly, Dr. Paul Lohmann®
is now able to put a major focus on the development
of nutritional supplements and APIs.
“With this investment, Dr. Paul Lohmann aims
at developing new solutions in cooperation with
our customers to increase profit and productivity
of our partners by providing innovative and appropriate
solutions for a large variety of application fields”,
said Dr. Uwe Günther, Company Executive and
CTO of Dr. Paul Lohmann®. “Our highly
skilled FEA scientists are experts in their field
and work in premises according to GMP and ISO standards
and dispose of cutting edge laboratory technology.”
Dr. Paul Lohmann® invites the industry to
discuss individual product development scenarios
at the trade shows the company will be exhibiting
in fall 2008:
CPhI Worldwide
- Frankfurt/Main, Germany
September 30 - October 2, 2008
hall 5 / booth 50B01
Supply Side West - Las
Vegas, NV, USA
October 23 - 24, 2008
booth 16073
Health Ingredients - Europe,
Paris, France
November 4 - 6, 2008
hall 1 / booth E017
Flexible
design and delivery through Stralfors print innovation
Stralfors introduces FMsix, a new printing
method which allows greater flexibility both in
terms of delivery time and order size when printing
cartons in many colours. Be just as creative in
your designs as before, print identical colours
time after time and forget the hassle of special
repro or design files. See the
results at ICSE 2008, exhibiting stand 41NE2.
Stralfors Pharmaceutical provides you with all
your secondary packaging requirements and offer
complementary services to create optimal solutions.
Their new printing technology FMsix, to be launched
at the ICSE in Frankfurt in September, combines
the advantages of FM screening with a reduction
of the number of colours used in order to print
a high quality design. Now you can produce any
design in a highly efficient and repetitive six-colour
system, regardless of the number of spot colours
originally used.
Mats Norell, Manager Stralfors Pharmaceutical
in Sweden leads the team of production flow specialists
that constantly reviews new technologies. ‘Our
clients are looking for a strategic and innovative
partner and FMsix forms a part of Stralfors’
recent technology investments which generate the
quality and delivery improvements required by
the industry. There is no room for inefficient
production in the pharmaceutical sector, and pharmaceutical
packaging is no exception’ he explains.
Stralfors
Business Concept
Stralfors, part of the Swedish Post Group Posten
AB, is an IT-focused Business-to-Business company
with print heritage, and providing total solutions
within the field of information transfer. Stralfors
develops, produces and delivers systems, services
and products for the efficient communication of
information crucial to
Stralfors
presents the ultimate in pharmaceutical labelling
Stralfors presents the ultimate in pharmaceutical
labelling Stralfors launches the latest in labelling
technology in the form of a multi-page label constructed
in one piece. If you are looking for a remarkably
secure and material efficient way to attach a
lot of information to your product, you should
visit Stralfors at ICSE 2008, exhibiting stand
41NE2. Stralfors Pharmaceutical is a leading supplier
of secondary packaging solutions for the pharmaceutical
industry.
The brand new label allows you to attach a multitude
of information to your product without facing
the risk of cross contamination in production.
As the label has been constructed in one piece,
it makes a material efficient and therefore cost-effective
alternative to other multi-page labels. The construction
also allows a better and more secure fit on the
container, minimising the risk of lost and damaged
information.
Hanne Wartenberg, Sales Manager at Stralfors Pharmaceutical
in Denmark has followed the developments made
by the one-piece product team consisting of technicians,
production and quality control staff, amongst
others. ‘Our clients realise that there
is a lot of time and money to be saved using innovative
processes throughout the production flow. The
one-piece solution is a response to their requirements,
aimed to give you that sometimes crucial difference
in efficiency and security’ she explains.
Stralfors has shown its strong commitment to the
pharmaceutical packaging sector by acquisitions
of the internal printing department of Novo Nordisk
and the printing businesses AB Cerbo Goteborg
and Medigrafik A/S. Hanne Wartenberg explains
that good partnering has taken the company to
where it is today. ‘New solutions are continually
formed between us and our clients. We often work
with very rudimentary ideas for years in order
to achieve the ultimate product for the industry’
she concludes.
Stralfors
Business Concept
Stralfors, part of the Swedish Post Group Posten
AB, is an IT-focused Business-to-Business company
with print heritage, and providing total solutions
within the field of information transfer. Stralfors
develops, produces and delivers systems, services
and products for the efficient communication of
information crucial to operating a business. The
Group has net sales of SEK 3.9 billion and 2300
employees at production sites in 8 countries.
Thermo
Fisher Scientific Announces its 2008 North American
Informatics
Conference
PHILADELPHIA
(August 11, 2008) – Thermo Fisher Scientific
Inc., the world leader in serving science, has scheduled
its annual North American laboratory Informatics
user group meeting, Thermo Informatics World (TIW),
from October 6-9, 2008 in Las Vegas, Nevada. The
conference will not only profile the company’s
strategic and product roadmaps, but also demonstrate
its latest informatics offerings that address the
growing data management and instrument integration
challenges of today’s laboratories.
TIW North America 2008 will provide users with enhanced
knowledge, tools and capabilities for integrating
Thermo Scientific LIMS (laboratory information management
systems) and CDS (chromatography data systems) across
laboratory instruments and the enterprise, increasing
collaboration and facilitating more informed decision
making. This year’s theme is “where
your solution is a sure thing.” Thermo Scientific
LIMS and CDS are utilized in laboratories around
the world and in diverse industries including chemicals,
environmental, food and beverage, forensics, metals
and mining, pharmaceuticals and bioanalytical, environmental
and wastewater.
The management of data is a key factor influencing
the overall productivity and performance of laboratories
in all major industries. Demonstrating its proven
expertise in the development of innovative laboratory
software solutions at TIW 2008, Thermo Fisher Scientific
will showcase its complete range of LIMS, CDS, pharmacokinetic-pharmacodynamic
software systems, and spectroscopy software systems.
The North American TIW annual user conference provides
industry professionals with a unique opportunity
to share cross-sector perspectives and become informed
on changing business requirements that drive the
enhancements and future direction of Thermo Scientific
informatics solutions. Designed to encourage customer
involvement, TIW features product breakout sessions,
including in-depth customer presentations, product
updates and onsite training provided by the Thermo
Fisher Scientific team of informatics experts.
TIW North America 2008 will take place at the JW
Marriott Hotel in Las Vegas. Early bird registration
is available until September, 5, 2008 and offers
a savings of $300. Group discounts are also
available. In addition, customers are invited to
present on a range of topics from sharing tips for
navigating the software to highlighting a successful
implementation. Presenters will receive a waiver
of the registration fee.
For more information about TIW North America,
please call +1 866-463-6522
Thermo Scientific is part of Thermo Fisher Scientific,
the world leader in serving science.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the
world leader in serving science, enabling our
customers to make the world healthier, cleaner
and safer. With annual revenues of $10 billion,
we have more than 30,000 employees and serve over
350,000 customers within pharmaceutical and biotech
companies, hospitals and clinical diagnostic labs,
universities, research institutions and government
agencies, as well as environmental and industrial
process control settings. Serving customers through
two premier brands, Thermo Scientific and Fisher
Scientific, we help solve analytical challenges
from routine testing to complex research and discovery.
Thermo Scientific offers customers a complete
range of high-end analytical instruments as well
as laboratory equipment, software, services, consumables
and reagents to enable integrated laboratory workflow
solutions. Fisher Scientific provides a complete
portfolio of laboratory equipment, chemicals,
supplies and services used in healthcare, scientific
research, safety and education. Together, we offer
the most convenient purchasing options to customers
and continuously advance our technologies to accelerate
the pace of scientific discovery, enhance value
for customers and fuel growth for shareholders
and employees alike. Visit www.thermofisher.com.
PennAkem,
a fully owned subsidiary of Minakem Group Acquires
Assets of Penn Specialty Chemicals, Inc.
(July 4, 2008)
Minafin, Minakem Group’s Holding Company and
Penn Specialty Chemicals, Inc.
(Memphis, Tennessee USA) are pleased to announce
that Penn’s chemical assets have been acquired
by PennAkem, a wholly-owned subsidiary of the French
Minakem Group.
Based in Memphis, Tennessee USA with production
facilities in the USA and China, PennAkem becomes
the global preeminent supplier of furfural and furan
derivatives. Known as the “Furan Chemistry
Specialists”, the acquired Penn’s business
produces all of their products starting from furfural.
Furfural is a renewable resource that comes primarily
from agricultural by-products such as corn cobs
and sugar cane bagasse. PennAkem performs various
chemistries with furfural to generate downstream
value-added products that are marketed and sold
globally to the pharmaceutical, agricultural chemical,
petrochemical, and plastic industries.
With this acquisition, PennAkem becomes the world
leading producer of furan, methyltetrahydrofuran
(a green solvent with several technical advantages
over tetrahydrofuran) and tetrahydrofurfuryl alcohol.
PennAkem’s product portfolio also includes
an array of difficult to produce multi-substituted
furan derivatives useful in chemical synthesis for
the Life Science Industries. "We are delighted
to add Penn's renewable resource chemistry to the
Minakem Group under the name of PennAkem”,
said Frederic Gauchet, President of Minakem Group.
“PennAkem brings us a very exciting family
of green building blocks based on agricultural by-products
not consumed in the food chain.” “These
new building blocks will greatly enhance our synthesis
offerings and are an alternative to petroleum-based
chemistry.”
Minakem Group is
also the owner of Minakem (France) and Chemtec Leuna
GmbH (Germany) engaged in custom synthesis for the
Life Science Industries with FDA-approved sites,
and Minasolve (France) devoted to the development
of Building Blocks.
The purchase of Penn’s Memphis site brings
an American industrial platform, which will help
the Minakem Group to better serve its American customer
base and the increasing number of chemical users
who desire to utilize greener chemicals made of
renewable resources.” We are very pleased
to welcome Penn’s team into the Minakem family;
we have been very impressed by its chemical capability
highly regarded in fine chemical industry.”
added Frédéric Gauchet. “With
several important projects that are starting immediately
with PennAkem, we anticipate strong synergies between
our Group’s companies to add significant value
to all our clients."
Drew McManigle, Penn’s Director said: "Penn
is pleased to be able to complete this transaction
that combines Penns furfural derivatives business
with such a pre-eminent entity as the Minakem Group”.
Report
into online counterfeit drug trade highlights why
local pharmacist remains safest source for patient
prescriptions
95.6% of online
pharmacies operate illegally; nearly two thirds
of online drugs found to be fake; problem moves
beyond lifestyle drugs to cancer and serious cardiovascular
diseases
Aegate, London, July 1 2008
Aegate, the patient safety communications company,
today issued its response to the European Alliance
for Access to Safe Medicines’ (EAASM) report
on the online counterfeit drug trade. According
to Aegate, the EAASM report demonstrates why patients
should avoid the alarming pitfalls of the online
drug industry. The report reveals that while purchasing
drugs online was once associated with lifestyle
medications such as Viagra, online pharmacies are
now supplying life-saving medicines, such as cancer
and seriouscardiovascular diseases. This development
is putting a worrying 3 in every 5 patients at serious
risk from the effects of substandard medication.
The report also highlights that 94% of the online
pharmacies surveyed do not reference a named verifiable
pharmacist and 50% of the medicines purchased do
not include a patient information leaflet. This
raises serious concerns over how patients can be
armed with the correct information to take the drugs
as intended. These findings are particularly relevant
since Forrester Research estimates that 30-40 per
cent of patients do not get the full benefit from
their treatment as they are uninformed as to how
to take the drug correctly.
Gary Noon, CEO of Aegate, said: “The findings
from the report reinforce just why patients should
tread so carefully when thinking about purchasing
drugs online. Patients would be safer returning
to traditional pharmacies that can not only provide
them with the reassurance that the medication they
are taking is safe, but can also advise them on
how to take the medication correctly and spot any
potential risks from co-medications. Today the role
of the traditional pharmacist is of paramount importance.
The professional point of contact between the patient
and the pharmacist can provide education, counseling
and validation of good quality drugs, all of which
are missing from many online pharmacies. The importance
of providing accurate information to the patient
at the point of dispense should not be underestimated.”
Aegate provides a tool to high-street pharmacists
that allows pharmacies to be able to provide such
reassurance and advice. Their patient safety communication
service is currently in operation in three European
markets - Belgium, Greece and Italy. It enables
the pharmacists to have an enhanced relationship
with patients by providing relevant and rapid patient
safety information directly from pharmaceutical
companies or regulators that they can act on at
the point of dispensing.
Jim Thomson, chair
of the EAASM, concludes: “We cannot underestimate
just how dangerous this illegitimate online drug
industry has become to the patient. These criminals
are ruthless in their exploitation of people with
life-threatening diseases, which is risking their
health, and in some cases, their lives. Therefore,
it is of paramount importance to raise awareness
of the problem and make the patient aware of the
pitfalls, while also reminding them how best to
ensure the drugs they are prescribed and dispensed
are both of good quality and safe to use.”
About Aegate
Patient safety communications company Aegate, provides
a unique patient safety network that opens a direct,
IT enabled communications channel between pharmacies
and pharmaceutical companies. The channel communicates
real time
pertinent information at the time of dispense.
For pharma companies they can utilise the Aegate
network to reach the pharmacy (and patients) directly
with communications at the time their products are
being dispensed. Whilst for the pharmacist it offers
assurance that good quality
medicines are being delivered to patients via the
distribution of relevant and timely information
at the time of dispensing - increasing confidence
in patient safety. The Aegate service also supports
the professional pharmacist in extending their advisory
capacity in serving patients.
The service is offered via two separate propositions
- AegatePROTECT™ which is Aegate’s tangible
commitment to corporate social responsibility and
patient safety and AegateREACH™ which provides
opportunities for pharmacy engagement. The
Aegate service is currently in operation in Belgium,
Greece and Italy, with plans in place for further
growth across Europe in 2008.
Aegate is supported by a sole investor, Ipex Capital
(www.ipexcap.com)
who is an independent, UK-based venture capital
company providing funding to early stage companies.
Formerly the venture arm of PA Consulting (www.paconsulting.com),
Ipex Capital not only provides Aegate with independent
funding but works closely with PA Consulting providing
us with access to PA'sbroad expertise and reach.
Hovione’s
sales grow 11%
Sales reach USD 103.7 million for the fiscal year
ended March 31st 2008.
Loures,
Portugal,
June 27th, 2008 - Hovione
announced today
that the consolidated sales for the fiscal year
ended March 31st 2008 amounted to USD103.7m, representing
a growth of 11% over the previous year.
This is Hovione’s
first year beyond the USD 100 million mark. This
sales increase reflects the drug approvals by
our customers both in the Innovator as well as
the Generic segment. Hovione’s offering
also includes the fast growing particle
design and inhalation formulation services.
All of our 4 businesses have a growth outlook
and present synergies between them.
In 2007 Hovione invested significant amounts
in particle design technologies, in new production
lines and in the constant upgrade of our facilities
worldwide. We have concluded the acquisition
of a 75% stake in the share capital of Zhejiang
Taizhou Hisyn Pharmaceuticals Co, Limited (Hisyn)
in December 2007 and Hovione retains the right
to acquire the remaining 25% at a future date.
Hisyn provides us with an excellent opportunity
to leverage our 25 years of operations in Hong
Kong and Macau, and positions Hovione ideally
for a low cost, high volume strategy in contrast
agents.
“Despite the negative economic environment,
we face 2008 with optimism. In 2005 we set a goal
to be selling $150m by 2010 with all the sales
increase driven by organic growth. I expect
us to be ahead of target this coming year.”
adds Guy Villax, Chief Executive.
Hovione is
an international group specializing in the development
and compliant manufacture of active pharmaceutical
ingredients, serving exclusively the pharmaceutical
industry. With a
50-year track record, Hovione offers advanced
technologies as well as APIs for all drug delivery
systems, from oral to injectable and from inhalation
to topical applications. With
FDA inspected plants in Europe, the Far East and
the US, Hovione is committed to the highest levels
of service and quality. Specializing
in complex chemistry and in particle engineering,
Hovione offers all services related to the development,
manufacture and pre-formulation of both new chemical
entities (NCEs) and existing APIs for off-patent
products.
For further
information about Hovione, please visit the Hovione
site at www.hovione.com
or contact Corporate Communications (Isabel Pina,
+ 351 21 982 9362, e-mail: hello@hovione.com).
Entropy
Solutions and SCA Cool Logistics Introduce GREENBOX
to Life Science Industry, Announce Partnership
Innovative packaging technology keeps
contents at consistent temperature for more than
five days, eliminates spoilage, is environmentally
responsible and reduces distribution-related expenses
up to 65 percent
Entropy
Solutions, Inc., a Minneapolis, Minn.-based thermal
technology development company and SCA Cool Logistics,
a UK-based packaging company, today announced
the introduction of GREENBOXTM Thermal Management
System. Designed to transport pharmaceuticals,
biologics and blood supplies, GREENBOX is capable
of maintaining narrow temperature ranges for extended
durations of time – up to 120+ hours, regardless
of external environmental conditions.
GREENBOX benefits the pharmaceutical and life
science industries in several ways, for example:
No spoilage: In the past, shipping temperature-sensitive
goods internationally, cross-country or even
to outlying or rural areas has resulted in enormous
amounts of product spoilage. Because GREENBOX
maintains a consistent temperature for up to
five days, the risk of spoilage is now virtually
non-existent.
Any-day shipping: The majority of temperature-sensitive
goods are shipped overnight express due to limited
thermal protection with current shipping technology.
Because GREENBOX maintains temperature for up
to five days, customers can ship road freight–
even on Fridays – typically resulting
in a 65 percent reduction in shipping and distribution
expenses.
Greater payload efficiency: GREENBOX offers
twice the payload space over competitors because
of its innovative and streamlined thermal management
system – nanotechnology combined with
optimal amounts of phase change material.
Reduction in distribution-related expenses:
Customers can save up to 65 percent on distribution-related
expenses due to GREENBOX’s unique, reusable
design. In contrast with typical single-use
systems, GREENBOX can be reused again and again,
with current customers experiencing up to 50
times of reuse.
Instant-pack protocol: GREENBOX features an
instant-pack protocol – a simple five-step
process allowing customers the ability to pack
payload at its specified temperature without
thermal shock.
The first reusable shipper: Because of the
resilient nature of GREENBOX customers can use
one box up to 50 times, making it the industry’s
first reusable thermal shipper. In the United
States (and soon in Europe), reclamation centres
gather used GREENBOXes, then inspect, clean
and re-certify them for re-use.
Sustainability: GREENBOX’s innovative
materials used are also 100 percent recyclable.
When the bright green, hard plastic outer shell
and Thermal-Lok TM insulating panels reach the
end of their lives they are ground down and
made into new shells and panels. In addition,
GREENBOX features biodegradable, non-petroleum,
non-toxic phase change materials.
Meets “green” initiatives: Many
of today’s leading pharmaceutical companies
employ green initiatives and GREENBOX is a perfect
fit. It’s the industry’s first and
only completely sustainable thermal packaging
system, created with 100 percent recyclable,
organic-based, non-toxic and fully biodegradable
components.
“We believe GREENBOX can truly revolutionize
the life science industry,” said Eric Lindquist,
President of Entropy Solutions. “With the
Entropy Phase Change Technology at the core of
our system, we’re empowering the industry
to ship life-saving drugs with more confidence
than ever before and save significantly on distribution
costs while doing so.”
Exclusive Partnership
Entropy Solutions and SCA Cool Logistics also
announced an exclusive distribution partnership.
SCA Cool Logistics now holds the rights to manufacture
and distribute GREENBOX, as well as other Entropy
Solutions products. This means that whereas previously
available in North America alone, GREENBOX will
now reach customers throughout Europe, Australia,
New Zealand and Singapore.
“Reaching customers worldwide is crucial
to our company’s mission,” said Eric
Lindquist. “SCA Cool Logistics is the European
market leader in temperature-controlled packaging
and together we can provide our global customers
with the highest quality, most effective thermal
packaging solutions.”
SCA Cool Logistics is a wholly owned subsidiary
of SCA Packaging, a global packaging company with
€3.5 billion in revenue, whose customers
include the world’s top 20 pharmaceutical
companies.
“We have a long-standing reputation of
providing the most innovative thermal shipping
solutions,” said Kevin Valentine, Managing
Director of SCA Cool Logistics. “That’s
why we are proud to partner with Entropy Solutions
to offer GREENBOX to our customers. During extensive
testing the GREENBOX provided excellent thermal
performance. By combining innovative phase change
technology in an environment-friendly design,
GREENBOX is the perfect fit to meeting our customers'
temperature-sensitive packaging needs, whether
they're shipping across town or across continents.”
About Entropy Solutions, Inc. Entropy
Solutions, Inc. is a thermal technology development
company with its global offices based in Minneapolis,
Minn. The company’s mission is to provide
innovative, cost-effective, temperature-controlled
solutions for the transport and distribution of
temperature-sensitive products throughout the
world. Entropy Solutions’ GREENBOXTM technology
is an innovative and next-generation passive thermal
breakthrough in cost-effective, highly efficient
shipping containers. Using patented phase-change
technology, the system is capable of maintaining
narrow temperature ranges for record durations.
The company’s primary focus is the life
science industry, where the ability to maintain
global regulators mandated temperatures during
the transport and delivery of temperature-sensitive
pharmaceuticals, biologics and blood products
are crucial to saving lives and advancing medical
discoveries.
About SCA Cool Logistics
Forming part of the SCA Packaging Group, SCA
Cool Logistics is focused on designing, testing
and qualifying temperature-controlled packaging
solutions to meet all customer requirements. Based
in the United Kingdom, the company manufactures
products worldwide, enabling the offer of a swift
supply response to all customers.
SCA Cool Logistics works predominantly on solutions
for the pharmaceutical, clinical trials and distribution
industries, handling the needs of a wide range
of customers, from small biotech companies to
multi-national pharmaceutical corporations.
The heart of the business is design and the UK
site has the largest test facility in Europe with
23 environmental test chambers from which temperature-controlled
packaging can be developed and qualified.
At SCA Cool Logistics the ethos is “Striving
to be a pleasure to do business with” and
this means that a flexible approach to design,
customer service and supply is required, coupled
with a strong understanding of the differing levels
of regulatory restriction and supply chain complexity.
For more information, please contact SCA Cool
Logistics at: cool.info@sca.com
Vetter
Strengthens Management Team
Ravensburg, May
14, 2008 - Vetter’s top management team is
being strengthened. As of June 1, 2008, Peter Soelkner
will be heading a number of divisions at the Ravensburg-based
company, which specializes in the filling of prefilled
injection systems. His new tasks will include Global
Key Account Management, Corporate Marketing, Supply
Chain Management and Project Management. Soelkner
will be joining the current Managing Directors Max
Horn and Thomas Otto in handling company business.
Thanks to his 10 years in sales, Peter Soelkner
has extensive experience with the international
pharmaceutical and biotech industries that he will
be bringing to his new position. Soelkner's previous
post was as Vice President Global KAM at Stedim
Biotech, USA. His tasks there included managing
the successful merger of Sartorius and Stedim to
form Sartorius Stedim Biotech. Vetter Pharma-Fertigung
GmbH & Co. KG is already familiar with Peter
Soelkner’s work. Prior to his posting abroad,
he was employed from 2003 to 2007 as Director of
the Key Account Management at Vetter. He managed
the implementation of the “End to End Supply
Chain Organization” concept at Vetter, thus
attaining an
"Operational Excellence Class A" certification
for the company within a record time of 11 months.
Peter Soelkner began his career at Sartorius AG
in 1992 and moved to Sartorius North America in
1998. While working at Sartorius, Peter Soelkner
held a number of international management positions,
notably in Research & Development, Marketing,
Key Account Management and General Management. The
graduate in Chemical Engineering (Dortmund Technical
University) also holds an MBA from Columbia University,
New York.
“Peter Soelkner is our candidate of choice,"
says Max Horn, Managing Director at Vetter Pharma-Fertigung
GmbH & Co. KG. “He has the necessary experience
in international management and a great deal of
expertise in the pharma and biotech industries,
plus he is already completely familiar with the
structures and products of our company. This makes
him the perfect man for us.” “We are
really looking forward to welcoming Peter Soelkner
on board,” adds Thomas Otto, the other Vetter
Managing Director. „Together, we will continue
on the successful course we have set."
About Vetter
Pharma-Fertigung GmbH & Co. KG:
Vetter is an independent international specialist
in the aseptic filling of syringes, cartridges and
vials.
Based in Ravensburg, Germany, Vetter also produces
its own injection systems, such as the Vetter
Lyo-Ject® dual-chamber syringe. With about 1,900
employees worldwide, Vetter holds nearly 140
patents and has longstanding experience in handling
client products and processes approved by the FDA,
the EMEA and other authorities. In 2007, the company
also received the go-ahead as a foreign manufacturer
for the Japanese pharmaceutical market from Japan’s
Ministry for Health, Labor and Welfare. Additionally,
Vetter has received two awards for its new facility
Ravensburg Vetter South (RVS): The Facility of the
Year Award 2007 (Process Innovation category) and
the European Outsourcing Award 2007 (Most Improved
Process/Plant/Facility category).
Vetter Development Service provides support for
its pharmaceutical and biotech clients in the early
stages of development, from clinical phases and
regulatory approval to worldwide product launch.
Vetter Commercial Manufacturing handles the entire
production process, from compounding and
aseptic filling to the final packaging of a product.
Vetter Solutions’ patented application systems
enable clients to compete more effectively throughout
the world.
Guildford,
United Kingdom, April 11th 2008 -
IDBS, a provider of drug discovery data management
solutions, today announced that the global pharmaceutical
company Boehringer Ingelheim (Ingelheim,
Germany) has purchased IDBS’ predictive
modelling technology PredictionBase for use at
its Biberach an der Riss research site.
Scientists at the Biberach facility, where research
into diseases of the central nervous system (CNS),
metabolic diseases and respiratory diseases is
centred, will use PredictionBase to build and
deploy and distribute predictive ADME QSAR models
using existing data.
Boehringer Ingelheim sought a solution that would
help reduce the effort required for scientists
to perform prediction manually, while also efficiently
distributing valuable drug discovery knowledge
throughout the company. PredictionBase provided
the required predictive technology to integrate
with existing Boehringer Ingelheim IT tools to
form an automated workflow, allowing scientists
to save time by prioritizing work, so improving
efficiency.
Neil Kipling, founder
and CEO of IDBS, commented: "Increasingly,
organizations are opting for predictive technologies
that help reduce costs incurred by failed candidates
by weeding out potential failures before screening
begins. Boehringer Ingelheim sought to
increase efficiency of the candidate identification
process by introducing an automated workflow.
Use of PredictionBase has helped its scientists
streamline working practises when dealing with
larger volumes of data.” He added: “By
providing scientists with a tool to create, analyze
and validate predictive models, PredictionBase
enables the easy generation and distribution of
knowledge across organizations.”
About IDBS: IDBS is
a leading provider of integrated software solutions
to the life sciences industry. Maximising the
value of research data by enabling organisations
to capture, store, share and use data efficiently
and effectively, whilst protecting intellectual
property across the spectrum of discovery activities.
Headquartered in
Guildford, UK, IDBS has U.S. offices in California,
New Jersey and Massachusetts. IDBS partners with
CTC Laboratory Systems in Japan and a network
of distributors to market IDBS products and services
in Asia. Founded in 1989, IDBS employs more than
150 people worldwide.
BMG
LABTECHS´s PHERAstar Plus sets new standards
in HTRFÒ , luminescence
and fluorescence polarization reading
To satisfy the ever-increasing demands of the
HTS community a new version of the highly successful
microplate reader PHERAstar is available from
BMG LABTECH, the PHERAstar Plus. The PHERAstar
Plus features Advanced HTRFÒ / TR-FRET,
Advanced Luminescence, and Advanced Fluorescence
Polarization reading modes by integrating the
latest technological advancements in optics and
electronics. Coupled with the new powerful data
analysis software package MARS, these new features
extend the application versatility of the PHERAstar
Plus.
The PHERAstar Plus is a simultaneous dual emission
HTS microplate reader offering all leading
detection technologies including fluorescence
intensity / FRET, fluorescence polarization, time-resolved
fluorescence / TR-FRET, laser-based AlphaScreenÒ,
luminescence / BRET, and UV/Vis absorbance. The
new instrument provides both enhanced HTRFÒ
performance with market leading Z’ and TR-FRET
ratio performance and a fourfold increase in luminescence
sensitivity. This is made possible by BMG LABTECH’s
innovations in the modular optical system combined
with the unique well-proven detection technology.
The PHERAstar Plus is the only microplate reader
on the market with five photomultiplier tubes
(PMTs) and Simultaneous Dual Emission (SDE) technology
optimized for specific reading modes and the capability
to capture TR-FRET decay curves in real-time for
assay optimization.
The
PHERAstar Plus will be delivered with a new version
of BMG LABTECH’s established Reader Control
and a completely new MARS Data Analysis Software
with significant ease-of-use enhancements such
as S/N, Z’, and many other standard calculations.
The Wizard creates an easy step-by-step calculation
of a standard curve and the Template Manager is
an excellent tool for building complex data processing
protocols. Thus, user-defined data analysis is
done simply with one click of the mouse. Improved
robotic integration capabilities, digital signature
and the 21 CFR part 11 compliance of MARS complete
this new software.
Established in 1989, BMG LABTECH is a global manufacturer
of microplate measurement and handling systems for
basic research and High-Throughput Screening. We
focus on microplate readers with a wide variety
of optical detection systems in conjunction with
integrated liquid handling equipment. We are committed
to bringing you innovative technology with the reliability
and quality that you expect from BMG LABTECH. Visit
our website for more information on the PHERAstar
Plus: http://www.bmglabtech.com/products/microplate-reader/instruments.cfm?product_id=9
FDA
gives Vetter the green light
Ravensburg, February 27, 2008 - Vetter Pharma-Fertigung
GmbH & Co. has been granted approval by the
Food and Drug Administration for the production
of a new client drug. Vetter, which provides contract
manufacturing services for pharmaceutical and
biotech companies, will now begin filling an innovative
drug at its Ravensburg Vetter South (RVS) facility.
The latest FDA client product approval underscores
the competence of the world leader in aseptically
pre-filled injection systems used in the production
of biotechnological
and complex medications.
"For us, the approval by the Food and Drug
Administration is a vital step in our corporate
development," said Thomas Otto, Vetter’s
Managing Director. “It means that we can
continue expanding our business. It also secures
our jobs, our investments and our future projects.
In addition, it reinforces our position as an
expert in the filling of sensitive substances.”
Vetter currently has a staff of about 1,900. The
company works for numerous international pharmaceutical
and biotech firms. Vetter has already passed several
FDA inspections with excellent marks.
About Vetter Pharma-Fertigung
GmbH &
Co. KG:
Vetter is an independent international specialist
in the aseptic filling of syringes, cartridges and
vials. Based in Ravensburg, Germany, Vetter also
produces its own injection systems, such as the
Vetter Lyo-Ject® dual-chamber syringe. With
about 1,900 employees worldwide, Vetter holds nearly
140 patents and has longstanding experience in handling
client products and processes approved by the FDA,
the EMEA and other authorities. In 2007 the company
also received the go-ahead as a foreign manufacturer
for the Japanese pharmaceutical market from Japan’s
Ministry for Health, Labor and Welfare. Additionally,
Vetter has received two awards for its new facility
Ravensburg Vetter South (RVS): The Facility of the
Year Award 2007 (Process Innovation category) and
the European Outsourcing Award 2007 (Most Improved
Process/Plant/Facility category).
Vetter Development Service provides support for
its pharmaceutical and biotech clients in the early
stages of development, from clinical phases and
regulatory approval to worldwide product launch.
Vetter Commercial Manufacturing handles the entire
production process, from compounding and aseptic
filling to the final packaging of a product. Vetter
Solutions’ patented application systems enable
clients to compete more effectively throughout the
world.
BMG
LABTECH releases the new evaluation software, MARS
Offenburg - Germany – BMG LABTECH GmbH,
the worldwide leader in innovative microplate
reading technology announces the release of the
new Microplate Reader Analysis and Data Reduction
Software, MARS.
BMG LABTECH´s microplate readers are used
in pharmaceutical, biotech, and academic labs.
They have been recognized in premier peer-reviewed
publications to provide high quality data in the
life sciences. Based on a friendly graphical user
interface, the MARS software now allows analysis
and display of multiple measurement methods and
has no limitation regarding the number of data
points.
The most common detection modes include absorbance,
luminescence, fluorescence intensity, fluorescence
polarization, time-resolved fluorescence, and
time-resolved fluorescence resonance energy transfer
(TR-FRET), to study compound solubility, antioxidant
capacity, protein-protein binding, nucleic acid
concentration, and second messengers such as ATP
and cAMP.
MARS works on the NEPHELOstar, the OPTIMA- and
OMEGA- series of microplate readers as well as
the high-end PHERAstar multidetection microplate
reader. Compatibility for the NOVOstar will be
available in April, 2008.
The MARS wizard creates an easy step-by-step
calculation of a standard curve and the Template
Manager is an excellent tool for building complex
data processing protocols. New features include
powerful sort and order functionality, averaging
of raw and blank corrected data, lock on data
trace, automated or user-defined range adjustment,
zoom functions, and a curve fitting library to
allow fast calculation of EC50, IC50, r2, and
CV values.
MARS provides results quick and easy and user-defined
data processing is done simply by one click of
the mouse.
Digital Signature and the 21 CFR part 11 compliance
of MARS complete this new software package. For
more information please contact your local BMG
LABTECH representative or visit our website: www.bmglabtech.com.
BR
Pharma’sU.S.
subsidiary Launches New Website www.pharamarama.com
to Highlight Firm's
Global Expertise in Comparator Trial Supply and
Named Patient Programs
The new Website coincides with the establishment
of Pharmarama’s
U.S. sales and marketing office in Boston and highlights
the firm’s capabilities in the growing fields
of comparator
drug sourcing for clinical trials and providing
drugs for named
patient programs worldwide. The company
maintains its headquarters in London, England and
has additional offices in Germany.
“We are in such a dynamic business that we
needed to have a site that provided our clients
and prospects with easily accessible information
about our company and its capabilities,” said
Tammy
Bishop, Pharmarama’s vice president
of U.S. business development. “This new site
will also serve as an interactive communication
medium with our clients, keeping them up to date
on the latest developments in the field and providing
useful links to industry resources.”
Pharmarama
was founded in 2006 by Ben
Rabin as the U.S. affiliate of U.K.-based
BR
Pharma Limited, which first gained recognition
for obtaining regulatory permission to import Ritalin
SR into the U.K. Rabin, a pharmacist with over 40
years in the retail and wholesale pharmaceutical
industries, and BR Pharma have provided over a decade
of service to the world’s leading pharmaceutical
companies and clinical research organizations sourcing
and procuring pharmaceutical products for clinical
trials, as well as providing services for named
patient programs. Pharmarama works in collaboration
with BR Pharma as a single point of contact for
the sourcing, repacking, blinding and distribution
of comparator drugs worldwide.
“We strived to create
a site that would emphasize the key characteristics
of the company - including its extensive track record,
consultative approach to service and decades of
experience in the supply of medicines worldwide,”
said Marcia Polese, principal of the integrated
marketing firm Polese
Clancy, which developed the site. “We
focused on the terms reliability, flexibility and
know-how to characterize the key differentiators
of the firm and deployed navigation that highlights
Pharmarama's named patient and comparator drug services.”
Pharmarama’s named
patient programs allow for the supply and
use of unlicensed medicines under strictly limited
conditions to meet the special needs of a particular
patient where a licensed equivalent does not exist.
Named patient medicines include medicines that are
not yet licensed in a territory, as well as investigational
drugs awaiting approval. Pharmarama works with leading
pharmaceutical companies in establishing formally
structured named patient programs in the pre-launch
phase of a medicine’s lifecycle.
Comparator drugs are used in clinical trials to
compare therapies under review to current therapies
commercially available in the market. An estimated
20 percent of all clinical pharmaceutical studies
globally use comparator products. Pharmarama provides
validated
comparator drug services – with speed,
accuracy and the highest degree of ethical standards
– to the world’s leading pharmaceutical
companies and clinical research organizations.
About Pharmarama Pharmarama
is a licensed wholesaler and importer of licensed
and unlicensed medicines, based in London, England,
with offices located in the United States and Germany.
The company, in partnership with BR
Pharma Limited, provides validated comparator
drug services such as sourcing, supply chain management
and support services, including drug warehousing,
custom pharmaceutical manufacturing, packing and
translation services.
Carrying on a tradition for more than 65 years,
the Sheffield™ brand continues a reputation
for excellence in providing cGMP compliant ingredients
to the pharmaceutical excipient industry. Sheffield™
Pharma Ingredients is a leading manufacturer of
pharmaceutical grade lactose excipients, glycerides,
coatings and flavors for innovative drug delivery
systems.
You may have known us as part of Quest International
or Kerry, but throughout our long history, Sheffield
Pharma Ingredients has always been dedicated to
meeting the unique demands of the pharmaceutical
industry.
Drawing upon worldwide resources and providing
a global technical platform, Sheffield™
Pharma Ingredients provides unique, technology-driven
solutions to meet any customer’s need. With
state-of-the-art applications and product development
capabilities, Sheffield™ Pharma Ingredients
is committed to the continuing development of
consistent, high quality products backed by unparalleled
service, technical support and formulation customization
capabilities.
Since the January 1, 2007 strategic sales and
marketing alliance with Foremost Farms® USA,
Sheffield Pharma Ingredients is uniquely positioned
to deliver the original DC lactose excipient product
lines, Foremost Fast Flo and Sheffield Anhydrous
Direct Tabletting.
Most recently, Sheffield™ Pharma Ingredients
has launched two new functional pharmaceutical
excipient systems: Sheffield™ Clear Coating
Systems and Sheffield™ Tabletting Systems.
The Sheffield™ Clear Coating Systems are
a complete one-step clear aqueous film coating
systems. The Sheffield™ Tabletting
Systems are orally dissolving and enhanced performance
excipient systems designed for use in pharmaceutical
direct tabletting operations. These complete
functional systems require only the addition of
the active ingredient to produce complete orals
dose formulations.
To find the highest commitment from an experienced
partner that works to your standards, visit us
at sheffield-products.com
or call a Sheffield expert near you.
CphI Booth# 20L49 / Hall 20
A Kerry Group Business
AlpVision
Krypsos™ open platform to combat counterfeits
has successfully achieved compliance
with the software and quality requirements of the
pharmaceutical industry and health authorities
Krypsos is a server-based online authentication
system managing the Cryptoglyph packaging covert
security solution, which only requires standard
ink and standard printing processes (offset, rotogravure,
laser, inkjet, etc.), as well as other security
features such as Fingerprint™, the AlpVision
detection solution based on intrinsic characteristics
of the product. Third party overt features such
as Bar Codes, two dimensional matrix codes or
OCR can also be managed.
For major deployments, which will bring covert
protection to over a billion products worldwide
by first quarter 2008, AlpVision Krypsos successfully
achieved compliance with the FDA 21 CFR Part 11
requirements for Electronic Records and Electronic
Signatures (ERES) issued by the Department of
Health and Human Services of the US Food and Drug
Administration (FDA).
The Krypsos online authentication solution enables
branded product manufacturers to provide their
supply chain with a single point of contact for
both fraud detection and genuine product authentication.
It also provides valuable logistics data, such
as gray market consolidation, and can generate
helpful online notifications for mobile commerce.
Krypsos meets FDA 21 CFR Part 11 requirements
providing the following functionalities:
Audit trail documentation;
Electronic records;
Advanced security controls and password protection;
Event reporting and notification including:
times, actions, users, and more;
Central data storage in a single SQL database.
The Computer Systems Validation
(CSV) was performed in compliance with the V-Model,
which defines the relevant project documentation
under the responsibility of either the customer
or AlpVision.
AlpVision has also a full Quality Assurance (QA)
system in place, which notably includes: development
standards, document management, operational handbook,
network and security management, risk analysis and
contingency planning.
The management and development teams of AlpVision
are proud to announce this important step, showing
its ability to master complex software development
in compliance with extremely severe QA policy established
in the environment of large multinational firms.
AlpVision is also proud to see its anti-counterfeiting
solutions adopted by major players in the fast moving
consumer goods (FMCG) and pharmaceutical industries,
in order to protect their products worldwide. The
AlpVision solutions include a covert security feature
to ensure the security of an overt product identifier.
The covert security feature is applied using only
standard ink and standard printing processes (offset
rotogravure, laser, inkjet, etc.). This technique
is perfectly in line with the anti-counterfeiting
requirements of the FDA Revitalization Act S.1082
for medicines delivered in the USA.
Further information:
AlpVision SA
Rue du Clos 12
1800 Vevey
Switzerland
Tel : +41 21 948 6464 avinfo@alpvision.com
Fax: +41 21 948 6465 www.alpvision.com
Pharmaceutical
Trials in Latin America Supported by the DIA
Latin America is becoming increasingly attractive
to the pharmaceutical industry for clinical trials
– this was just one of the conclusions to
come out of the Drug Information Association’s
(DIA) 43rd Annual Meeting held in Atlanta during
June. Delegates and speakers alike agreed that
the last few years have seen a growth in clinical
trials across multiple non-traditional regions
due to a lack of patient availability across the
EU, US and Japan, especially for the larger studies.
They agreed that China, India, Eastern Europe
and Latin America in particular were becoming
attractive propositions for conducting cost-efficient
trials with treatment-naïve patients. However,
they warned that regulatory, technical and logistical
challenges remained, as big manufacturers start
moving further into these emerging markets. Accepting
data from these studies is also forcing developed
countries to rethink their regulatory criteria.
The Latin American challenge was discussed as
part of one of the 400 regular, plenary and tutorial
sessions presented by more than 1,000 speakers,
including manufacturers, consultants and technology
providers. In the past, regulatory frameworks
in Argentina, Brazil and Mexico have posed a variety
of hurdles for pharmaceutical manufacturers looking
to operate within those countries. However, the
environment has recently improved, allowing companies
to work in accordance with international standards
and guidelines. This shift was said to be one
of the key reasons why Latin America is now a
viable proposition for clinical trials, according
to attendees.
Other issues covered at the event included the
controversial development of adaptive clinical
trials, the US FDA’s Critical Paths Initiative
and personalised medicine. Adaptive trials have
quickly become buzzwords in the pharmaceutical
industry as they have emerged from a theoretical
possibility to something that is practically applicable.
The critical factors in implementation remain,
however, such as creating an appropriate regulatory
framework, applying satisfactory designs and ensuring
that EDC, IVRS and SAS technologies are advanced
enough to be able to cope with the demands of
implementing such trials. Indeed, study blinding
issues, managing drug supplies, hiding design
changes from investigators and training requirements
still need further clarification.
Now more than four decades old, the annual event
has never been so popular. During the mid-80s
it was attracting about 700 delegates. But with
8,000 at the latest gathering and even more expected
at the next event in Boston, it is going from
strength to strength.
Introducing
BMG LABTECH’s new OMEGA family of microplate
readers
Introducing BMG LABTECH’s new OMEGA family
of microplate readers – The world’s
first multifunctional readers capable of capturing
a full absorbance spectrum (200 – 850 nm)
in less than 1 second per well, at a resolution
of 1 nm. This new family of readers also offers
fluorescence, luminescence and reagent injection
for kinetic based assays. The OMEGA with full
spectrum absorbance provides users with unmatched
flexibility and sensitivity to perform any assay
needed. Leave absorbance filters and monochromators
behind!
Further information
BMG Labtech GmbH
Tel: +49 781 969 680
Fax: +49 781 969 6867
Ingenia Technology Ltd has been named winner
of the Global Security Challenge 2006. The company
was awarded the $10,000 prize in recognition of
its breakthrough proprietary technology, Laser
Surface Authentication (LSA).
The Global Security Challenge (GSC) is an annual
competition to find the most promising security
technology start-up business in the world. It
is organised by MBA students at the London Business
School and sponsored by Smiths Detection, the
US Navy’s Office of Naval Research Global,
SAIC and University College London.
The aim of the GSC is to stimulate technological
innovation that will make us all safer without
encroaching on civil liberties. It is the first
business school competition to feed the growing
market for new security technology.
The finalists, including Ingenia, were selected
from around the world by a panel including scientists,
entrepreneurs, venture capitalists and a London
Business School professor. Ingenia passed through
three preliminary rounds before winning the award,
beating off strong competition from the four other
finalists.
Announcing their decision, the judges explained:
‘Our decision to select Ingenia Technology
was unanimous. Ingenia has developed a potentially
disruptive technology with global opportunities.’
Simon Schneider, co-director of the GSC and former
security consultant with IBM, said: ‘Ingenia
Technology has developed a remarkable new and
disruptive technology with wide-reaching applications
in both the commercial and government sectors.
Laser Surface Authentication has immediate potential
to reduce organised crime and terrorist funding,
as demonstrated by the high level of interest
being shown in the technology worldwide. Ingenia
is a worthy winner of the Global Security Challenge
to find the best new security technology company
in the world, and we wish them every success for
the future.’
Invented by Professor Russell Cowburn of Imperial
College London, LSA enables foolproof ‘fingerprinting’
of paper and plastic and could potentially be
used to:
Crack down on global terrorism
Crack down on the tobacco and alcohol ‘grey
market’
Protect against drug counterfeiting
Protect against identity and passport fraud
Protect against revenue fraud
Track and trace goods worldwide through the
supply chain
LSA reads the surface of the inherent structure
of man-made objects using a low-cost laser scanner
to effectively generate a naturally occurring
‘fingerprint’ and then stores the
information securely in a database.
The authenticity of the document, packaging or
object can be subsequently verified by another
simple scan with a handheld scanner, which will
check against the existing stored ‘fingerprint’.
The accuracy of measurement is often greater than
that of DNA, with certainty levels typically in
excess of 10 to the power 100.
Mark McGlade, director of business development
at Ingenia, was delighted: ‘We are very
pleased at being selected as the winner of Global
Security Challenge, against very strong competition.
LSA has the potential to completely transform
the way we approach security issues internationally,
and we are glad that our technology has now gained
global recognition.’
GSC has been welcomed by senior political figures
in the US as a creative approach that will encourage
entrepreneurship and improve security. The US
Senate Majority Leader Bill Frist said: ‘The
GSC is an example of the innovative thinking we
need to stay ahead of the security curve.’
Camera
Phone can identify counterfeit products worldwide:
another first from AlpVision SA
AlpVision, a leading solution
provider for brand protection and security printing
disclosed this new product and demonstrated it
live at Creative Packaging in Paris. With AlpVision
a simple click on a camera phone can distinguish
genuine brand products from fakes.
With packaging secured with AlpVision’s
patented Cryptoglyph covert security solution,
a picture taken with a mobile camera phone can
identify products as genuine or not.
The picture is sent via the mobile network to
a security server and analyzed to detect the presence
of the covert Cryptoglyph. Note that it is impossible
to replicate the Cryptoglyph. The server can be
managed by the brand owner or by a trusted third
party. If detected, the embedded, ciphered information
is decoded instantly identifying the batch or
serial number of the product as well as other
information contained in the security data base.
The solution also provides instant detection of
possible grey market activity.
An SMS is sent automatically back
to the camera phone confirming the product as
genuine or fake as well as indicating possible
fraudulent re-importation.
First developed to help field controllers
performing off the shelf inspection of pharmaceutical
and cosmetics products, the solution may be extended
and given to end-consumers either for buying on
the street or over the Internet.
Cryptoglyph is the only covert (invisible)
brand protection solution using standard visible
ink and standard packaging production lines. Millions
of products and documents are already successfully
protected by AlpVision.
New
Simplicity® System from Millipore Provides Ultrapure Water When and Where
You Need It
Billerica, Massachusetts --- February
28, 2006 --- Millipore Corporation today announced
the availability of a flexible ultrapure water
system that can be placed anywhere in the laboratory.
The new Simplicity system is easy to install and
produces ultrapure water on demand from pretreated
water (Elix® system, distilled, deionized
or reverse osmosis water). Designed for scientists
who require less than five liters of ultrapure
water per day, the system is suitable for the
production of mobile phases for chromatographic
separations, preparation of blanks and standard
solutions for spectrophotometry, spectroscopy
or other analytical techniques, as well as buffer
preparation for biochemical experiments.
The Simplicity system’s Type I water (18.2
MΩ·cm at 25 °C ultrapure water)
provides an economical alternative for laboratories
currently using bottled water. Also, as the Simplicity
system’s water is produced and used at the
point-of-use, the water quality is not subject
to contamination from containers or degradation
from airborne contaminants. For sensitive applications,
such as HPLC, GC and TOC analysis, the system’s
built-in dual-wavelength UV lamp (185 and 254
nm) reduces organic contaminants to < 5 ppb.
In addition, a range of final polishers is available
to provide bacteria-free, pyrogen-free or nuclease-free
water, depending on requirements.
The
Simplicity system fits easily anywhere in the
lab and its integrated, removable reservoir means
that no feedwater connection is needed. Maintenance
is reduced to changing the SimpliPak™ purification
cartridge once or twice a year—a procedure
that takes just minutes thanks to the snap-in
and-out cartridge. Other system features include
a design able to accommodate a wide range of laboratory
glassware and an intuitive graphic display that
clearly shows system parameters such as water
quality, reservoir level and pack replacement
information.
Millipore ’s Bioscience division delivers
complete solutions and services for pharmaceutical,
academic, life science, clinical and government
research laboratories. With more than 50 years of
experience, Millipore manufactures and markets several
thousands of products that accelerate drug screening
and improve sample preparation. For more information,
please contact Millipore Tech Service at 1-800-MILLIPORE,
781-533-6000 or visit www.millipore.com/bioscience.
Alberto
Frausin takes the helm of Zambon Group's pharma
business
Alberto Frausin, the new Managing
Director of Zambon Group
Milan, 31 January 2006 – The Board of Directors
of Zambon Group S.p.A. yesterday appointed Alberto
Frausin Managing Director of the Group's Pharma
Business.
The forty-nine-year-old Alberto Frausin, who
was previously General Manager of Manetti &
Roberts, has risen through a series of increasingly
senior roles in multinationals and Italian companies
with a strong international presence, such as
Kraft, S.C. Johnson, and Ferrero.
"We are all looking forward to the contribution
that Alberto Frausin's experience and knowledge
will bring the Group, particularly with regard
to leveraging the strategic strengths able to
sustain the growth of our activities and to identifying
the organisational forms best suited to developing
our pharmaceutical business", commented Elena
Zambon, President of the Board of Directors of
Zambon Group S.p.A., during a pause in the meeting.
“The Board of Directors”, concluded
Elena Zambon, “will continue to adopt our
established organisational model, based on a clear
distinction between the roles of shareholders
and management, dedicating the attention and energy
required to sustain the ongoing growth and development
of the Group, forging ahead in the same spirit
of independence that has distinguished our first
hundred years in business”.
Leading thinking worldwide: Zambon Group
S.p.A. With a reputation
for inventive and innovative thinking, flexibility
and customer focus, Zambon has grown to become
a leading pharmaceutical and chemicals company
with over 2,300 employees in 16 countries and
consolidated sales in the region around €500m.
Operating directly on three continents - Europe,
South America and Asia - Zambon is a multicultural
Group with close links to its local markets and
the international research community alike. These
strengths, combined with diversified research,
product and distribution channel strategies, ensure
that the Zambon consistently outperforms its competitors
and the market. We are justly proud of our reputation
for initiating trends on the leading edge of the
industry and the rich portfolio of ground-breaking
products and dosage forms with which Zambon improves
the quality of life of thousands of people worldwide.
Zambon Group was founded in Vicenza in 1906. www.zambongroup.com
FDA
Approves New Treatment for Gastrointestinal and
Kidney Cancer
The Food and Drug Administration (FDA) today
announced approval of Sutent (sunitinib), a new
targeted anti-cancer treatment for patients with
gastrointestinal stromal tumors (GIST), a rare
stomach cancer, and advanced kidney cancer. Today's
action marks the first time the agency has approved
a new oncology product for two indications simultaneously.
Sutent, which received a priority review and
was approved in less than six months, is a tyrosine
kinase inhibitor working through multiple targets
to deprive the tumor cells of the blood and nutrients
needed to grow.
"Today's approval is a major step forward
in making breakthrough treatments available for
patients with rare and difficult to treat forms
of cancer" said Steven Galson, MD, Director
of FDA's Center for Drug Evaluation and Research.
"New targeted therapies such as Sutent are
helping FDA expand options for patients for whom
there are limited alternatives."
According to the American Cancer Society, about
32,000 new cases of advanced kidney cancer and
5,000 cases of GIST are diagnosed each year.
Sutent was approved for the treatment of patients
with gastrointestinal stromal tumors (GIST) whose
disease has progressed or who are unable to tolerate
treatment with Gleevec, the current treatment
for GIST patients. While studying the treatment
in patients, researchers conducted an early (interim)
analysis of data that showed Sutent delayed the
time it takes for tumors or new lesions to grow
in patients with this rare type of stomach cancer.
Specifically, the median time-to-tumor progression
(TTP) for patients treated with Sutent was 27
weeks compared to 6 weeks for patients who were
not treated.
FDA also granted accelerated approval for Sutent
in the treatment of patients with advanced renal
cell carcinoma (RCC). In contrast to the approval
for GIST, which was based on the drug's ability
to delay the growth of the tumors, this approval
was based on Sutent's ability to reduce the size
of the tumors in patients. An overall response
rate ranging from 26-37 percent was found in patients
with metastatic kidney cancer whose tumors had
progressed following cytokine-based therapy.
"Today's approval of this drug for these
indications provides compelling evidence that
the use of alternative data endpoints allows us
to see the benefits of novel therapies earlier
in patients," said Richard Pazdur, MD, Director
of FDA's Office of Oncology Drug Products.
George Demetri, MD, Dana
Farber Cancer Institute, Boston, USA
Robert Motzer, MD, Memorial
Sloan Kettering Cancer Centre, NY, USA
The FDA has a long-standing commitment of providing
patients suffering from serious and life-threatening
diseases access to safe and effective treatments,
in some cases prior to FDA approval. In the GIST
clinical trial, significant clinical benefit was
determined through an early interim analysis of
data, thereby allowing researchers to convert
all patients in the trial to treatment. For the
RCC indication, the FDA used its accelerated approval
process, a regulatory mechanism that expedites
drug approvals for serious and life-threatening
diseases.
FDA worked with the product sponsor to offer
an expanded access program prior to approval,
making the product available to patients not enrolled
in a clinical trial. Currently, more than 1700
patients are being treated with Sutent through
the expanded access program.
"Expanded access programs have proven to
be an effective way to get treatment to patients
who need it most, especially in cancer,"
said Ellen Stovall, President of the National
Coalition of Cancer Survivorship. "There
needs to be a greater awareness among patients
and doctors about both the option to participate
in clinical research as well as in these expanded
access programs in order to make promising new
therapies available to as many patients as possible."
The most commonly reported Sutent-related side
effects included diarrhea, skin discoloration,
mouth irritation, weakness, and altered taste.
Patients treated with Sutent also experienced,
fatigue, high blood pressure, bleeding, swelling,
and taste disturbance. Hypothyroidism was also
observed.
Sutent will be distributed by Pfizer Labs, Division
of Pfizer, Inc. in New York, NY.
Agilent
Technologies Upgrades Cerity CDS for Pharmaceutical
QA/QC
Cerity CDS A.02.03 Reduces Operation,
Validation Costs through Enhanced Usability, Instrument
Control, Data Exchange
Waldbronn, Germany., Jan 17 th 2006 -- Agilent
Technologies Inc. (NYSE: A) has announced the
release of Cerity CDS A.02.03, a dedicated chromatography
data system for pharmaceutical quality assurance/quality
control laboratories, designed to enhance workflows
and facilitate compliance of pharmaceutical QA/QC
labs of all sizes.
"We've designed a complete package for today's
pharmaceutical QA/QC lab that adapts easily to
laboratory workflow to optimize efficiency and
productivity, while also providing close integration
with other internal and external systems,"
said Günter Nill, general manager, Pharma
Solutions Business, Agilent Life Sciences and
Chemical Analysis.
Cerity provides centralized management of chromatography
data for labs operating from just a few to hundreds
of instruments. Release A.02.03 now offers:
Tighter integration into customers' laboratory
structures and workflows, including project
data organization and object level security.
Better data import/export and programmatic
connectivity to external systems such as ERP,
LIMS, ELN and analytics.
New instrument diagnostics to enhance efficiency
and productivity.
Cerity CDS significantly reduces the time spent
on system qualification and validation. It offers
fully automated validation tools for analytical
hardware qualification and verification, as well
as software qualification. Cerity CDS offers many
features to facilitate FDA 21 CFR Part 11 compliance,
including version control, inherent data integrity
and an automatic, fully traceable audit trail
to ensure that no records can be overwritten.
Thus, Cerity CDS assures correct and validated
final results and it produces final results faster
than any other packages not tailored to the regulated
pharmaceutical laboratory environment. It provides
for Level-4 instrument control, including the
highest level security features such as active
handshake, error checking, automated tracking
of serial numbers and firmware revisions, and
advanced diagnostics. This means that records
of instrument and data acquisition are reliable
and trustworthy, according to current 21 CFR Part
11 guidelines.
Cerity A.02.03 scales up seamlessly from standalone,
single-user configurations to distributed multi-user,
multi-instrument configurations for labs with
100 instruments or more. It's based on industry-standard
software and protocols, minimizing demands on
IT. The built-in spreadsheet/custom calculator
eliminates time-consuming, error-prone manual
data transcription.
"We're protecting customers' investments
in Cerity for Pharmaceutical QA/QC by building
on technology such as instrument control through
LAN or Oracle-based data management," Nill
added. "Cerity CDS for Pharmaceutical QA/QC
also provides for integration of leading-edge
technologies."
Customers with a current Agilent Support Contract
will receive a free upgrade to Cerity CDS A.02.03
software.
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is the world's
premier measurement company and a technology leader
in communications, electronics, life sciences
and chemical analysis. The company's 21,000 employees
serve customers in more than 110 countries. Agilent
had net revenue of $5.1 billion in fiscal 2005.
Information about Agilent is available on the
Web at www.agilent.com.
ICON
Supports Amarin's European Pivotal Phase III Clinical
Trial
Dublin, Ireland, 09 January 2006 - ICON plc,
a global provider of development services to the
pharmaceutical biotechnology and medical device
industries, today announced that it will be conducting
Amarin's (NASDAQ:
AMRN) European Phase III clinical trial of MiraxionTM
in Huntington's disease.
In support of the European trial, ICON is providing
a range of development services including clinical
research management, data management, statistics
and CRF design services. The European clinical
trial is being conducted in collaboration with
EURO-HD. EURO-HD is a non-profit group of physicians
and other healthcare professionals dedicated to
the research and care of Huntington's disease
patients.
The European trial is a multi-centre, randomized,
double blind, placebo-controlled study of Miraxion
in up to 33 sites in Europe. Two hundred and forty
patients with Huntington's disease will be enrolled
in the trial over a 6-month period. The primary
endpoint will be to determine whether Miraxion
results in clinically and statistically significant
changes in the Total Motor Score-4 subscale of
the Unified Huntington's Disease Rating Scale
(UHDRS).
Dr. Peter Sowood, President of ICON Clinical
Research in Europe, commented:
"We are delighted that Amarin have chosen
us to play a significant role in the European
Phase III clinical trial of Miraxion. We have
successfully supported the roll-out of Miraxion's
US trial and we are committed to ensuring the
achievement of Amarin's key milestones in the
European phase of the trials."
Rick Stewart, Chief Executive Officer of Amarin,
commented: "The commencement of the 240 patient
European Phase III clinical trial in Huntington's
disease is a major milestone. We expect the European
trial will show positive progress as patient enrolment
accelerates and we feel reassured to have a partner
such as ICON, with its experience and knowledge,
collaborating with us on this key project."
FDA
GRANTS REVLIMID® NDA APPROVAL
SUMMIT, NJ (December 27, 2005) - Celgene
Corporation (NASDAQ: CELG )
announced that the U.S. Food and Drug Administration
(FDA) granted approval of REVLIMID (lenalidomide)
which is indicated for the treatment of patients
with transfusion-dependent anemia due to low-
or intermediate-1-risk myelodysplastic syndromes
(MDS) associated with a deletion 5q cytogenetic
abnormality with or without additional cytogenetic
abnormalities. REVLIMID will be available through
a REVLIMID Education and Prescribing Safety Program,
called RevAssist sm via contracted pharmacies.
"The clinical data
from a Phase II trial of 148 patients demonstrated
that Revlimid can reduce or even eliminate the
need for transfusions in many patients with del
5q MDS," said Dr. Alan List, Professor of
Oncology and Medicine, and Chief Division of Hematologic
Malignancies Hematologic Malignancies at H. Lee
Moffitt Cancer Center, Tampa, Florida, and the
study's lead investigator. "I am extremely
pleased with the FDA's action today."
The safety profile for REVLIMID has shown that
neutropenia and/or thrombocytopenia were the most
common adverse event (AE) and that patients may
require a dose adjustment. Other observed and
common AE's include diarrhea, pruritis, rash,
fatigue, constipation, nausea, nasopharyngitis,
arthralgia, pyrexia, back pain, peripheral edema,
cough, dizziness, headache, muscle cramp, dyspnea,
and pharyngitis.
"Being able to use an oral therapy such
as REVLIMID to treat del 5q MDS could reduce or
even eliminate the need for red blood cell transfusions
in MDS patients," said Dr. John Bennett,
Professor of Oncology in Medicine, Pathology,
and Laboratory Medicine, University of Rochester.
"The FDA approval of REVLIMID offers a new
therapeutic option to this particular group of
patients with myelodysplastic syndromes,"
said Graham Burton, M.D., SVP, Regulatory Affairs
and Pharmacovigilance for Celgene.
The timing of this approval will result in most
initial shipments of REVLIMID to be distributed
in early 2006. This later than anticipated approval
has also resulted in an increase in pre-launch
expenses of approximately $5 million, with 2005
full-year adjusted earnings per share now expected
to be approximately $0.36-$0.38 per diluted share.
RTS
Installs Second Clonal Cell Line Expansion System
THE UNIVERSITY of Bristol is developing a growing
reputation for its work in the growth of cell
lines. In part, this is because last year, an
automated cell line system developed with RTS
Life Science was installed, primarily for its
work on The Avon Longitudinal Study of Parents
and Children (ALSPAC). After this system proved
its success, a second system has been installed,
this time for the 1958 British Birth Cohort Study,
which is managed by St. Georges Hospital, London
and The Institute of Child Health, with the growth
of cell lines being outsourced to the team at
Bristol.
Essentially both modular systems automate the
tissue culture process that is vital to the development
of immortalised cell lines, providing a never-ending
supply of DNA for extensive genetic studies.
The technology behind the Bristol University
systems comes from RTS’ Assay-Platform systems,
which are primarily used by the pharmaceutical
sector for high throughput and ultra high throughput
screening. Karen Allison, product manager for
the Assay Platform family of products, explained:
“The flexibility inherent in the Assay-Platform’s
physical layout and the Sprint scheduling software
it uses, has translated into a proven application
for fully automated cell manipulation in multi-well
plates.”
The 1958 British Birth Cohort Study has followed
people born in that year from birth to the present
time. The studies have painted a detailed picture
of how life in Britain has changed over the past
50 years and have been used by policymakers to
assess the impact of government policies.
Once again, the University has received funding
from the Wellcome Trust, as well as collaborative
input from the ECCAC, the Europe-wide cell culture
organisation. Dr. Richard Wynn Jones, head of
biological samples in both ALSPAC and the 1958
Cohort, explained: “RTS Life Science created
a groundbreaking system to manage and carry out
the cell manipulations crucial to the ALSPAC project.
It was natural to turn to them when our first
system came under strain from the sheer volume
of work. As some of the cultures grown in the
1958 Cohort stay on the system for six weeks,
we knew we had to have an even more highly defensive
set-up than our first system. All the liquids
entering the new system, including the sterile
media, are run through a 0.1 micro filter, but
other than that, there is very little difference
between the new and the old systems. You could
say we stuck with a winning formula.”
Peripheral blood lymphocytes are isolated and
transferred to a single well of a 24 well plate
in which they are exposed to Epstein Barr Virus
(EBV). Once set up, the transforming cells are
subjected to the automated refeeding and expansion
process. Cells are diluted and expanded progressively
across the wells of the plate. Plates are barcoded
Under this agreement, Antares and Cognex technical teams will cooperate to develop and market new, high performance reading stations required to implement the next generation of Track&Trace systems.
Werum
is an internationally leading supplier of Manufacturing
Execution Systems (MES) for the pharmaceutical
and biopharmaceutical industries. It’s successful
and well-established MES product PAS-X is used
by 16 of the world's top 30 pharmaceutical and
biotech companies in more than 500 installations.
Werum delivers PAS-X as a turnkey, integrated
and ready-to- be-validated system. The comprehensive
range of functions built into PAS-X is the key
to quality and compliance and lays the foundation
for operational excellence initiatives in the
manufacturing and packaging of pharmaceutical
products. The company's MES-related services include
consulting, project management, validation support,
system integration, training, maintenance, hotline
support, and life cycle management. A global network
of local Werum offices and carefully selected
regional solution partners guarantees reliable
on-site support for clients. Founded in 1969,
the IT company employs more than 400 people at
its headquarters in Lueneburg, Germany, and at
eight other locations in Germany, France, the
United States, Japan, and Singapore.
About ISP International Specialty Products
Inc. (ISP) is a leading global supplier of specialty
chemicals and performance enhancing products for
a wide variety of personal care, pharmaceutical,
beverage and industrial applications. ISP produces
more than 500 specialty chemicals, which it markets
and sells worldwide. The company's headquarters
is located in Wayne, New Jersey, USA.
The
main purpose of the recirculation is to reintroduce
the fine non-captured particles into the cyclone
after those have been driven to the outer walls
of the re-circulator by centrifugal or electrical
forces. While this tangential gas stream is enriched
in particles, the axial gas stream exhaust to
the stack is practically invisible. -(2).gif)
About
InfraTrac
Terry Scannell, Supply Chain Manager at Structure-flex
comments: “The FIBC market is a fast
moving industry, where the demands of the consumer
dictate short lead times and J.I.T. deliveries
of the highest quality products at ultra-competitive
prices. In the past, Structure-flex has
manufactured products from its own facility; however,
as a result of the rapid increase in global trading
opportunities and the growth of customers’
own markets, the industry has seen the development
of new overseas supply routes which can offer
products of the highest quality whilst maintaining
excellent value for money.”
Media
Inquiries:
Stralfors
Business Concept
Entropy
Solutions, Inc., a Minneapolis, Minn.-based thermal
technology development company and SCA Cool Logistics,
a UK-based packaging company, today announced
the introduction of GREENBOXTM Thermal Management
System. Designed to transport pharmaceuticals,
biologics and blood supplies, GREENBOX is capable
of maintaining narrow temperature ranges for extended
durations of time – up to 120+ hours, regardless
of external environmental conditions. 
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The
PHERAstar Plus will be delivered with a new version
of BMG LABTECH’s established Reader Control
and a completely new MARS Data Analysis Software
with significant ease-of-use enhancements such
as S/N, Z’, and many other standard calculations.
The Wizard creates an easy step-by-step calculation
of a standard curve and the Template Manager is
an excellent tool for building complex data processing
protocols. Thus, user-defined data analysis is
done simply with one click of the mouse. Improved
robotic integration capabilities, digital signature
and the 21 CFR part 11 compliance of MARS complete
this new software.
etter
Pharma-Fertigung GmbH & Co. KG.gif){kind=tracking}
The
Simplicity system fits easily anywhere in the
lab and its integrated, removable reservoir means
that no feedwater connection is needed. Maintenance
is reduced to changing the SimpliPak™ purification
cartridge once or twice a year—a procedure
that takes just minutes thanks to the snap-in
and-out cartridge. Other system features include
a design able to accommodate a wide range of laboratory
glassware and an intuitive graphic display that
clearly shows system parameters such as water
quality, reservoir level and pack replacement
information. 
