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Multipharma Forges Co-operation for Supply Chain Services With Movianto; Europe's Leading Contract Logistics Provider
Advanced Cyclone Systems - Solving the problem of efficient powder recovery
InfraTrac uses quality approach to combat drug counterfeiting
Structure-flex opens supply chain route with China
Prefilled WFI Syringe Provides a High-Quality Solution for Drug Reconstitution
Pfeiffer invests EUR 12 million in new logistics and technology centres
Vetter launches Project Management Quality Assurance Program
As GPCR Space Becomes More Crowded, Drug Makers Show Affinity for Non-traditional GPCR Binding Sites
Millipore Introduces New Tools for Vascular Biology Research
Vetter Pharma Fertigung GmbH & Co. KG Launches New Subsidiary
Almac win ‘Exporter of the Year’ in economic awards
DHL secures £7m contract with Guy’s and St Thomas’ hospitals
Dr. Paul Lohmann® adds Fermentation Grade Calcium Formate to its portfolio
DHL expands healthcare offer with contract packing and kitting
Key Almac division celebrates 20 years of growth
BMG LABTECH  is proud to announce the launch of the next generation HTS microplate reader - PHERAstar FS
Hovione buys Pfizer’s Loughbeg API Facility
DPL Press Release Week 39 / 2008
Flexible design and delivery through Stralfors print innovation
Stralfors presents the ultimate in pharmaceutical labelling
Thermo Fisher Scientific Announces its 2008 North American Informatics Conference
PennAkem, a fully owned subsidiary of Minakem Group Acquires Assets of Penn Specialty Chemicals, Inc.
Report into online counterfeit drug trade highlights why local pharmacist remains safest source for patient prescriptions
Hovione’s sales grow 11%
Entropy Solutions and SCA Cool Logistics Introduce GREENBOX to Life Science Industry, Announce Partnership
Vetter Strengthens Management Team
Boehringer Ingelheim Chooses IDBS’ PredictionBase
BMG LABTECHS´s PHERAstar Plus sets new standards in HTRF, luminescence and fluorescence polarization reading
FDA gives Vetter the green light
BMG LABTECH releases the new evaluation software, MARS
BR Pharma’s U.S. subsidiary Launches New Website
Carrying on a tradition for more than 65 years
AlpVision Krypsos™ open platform to combat counterfeits has successfully achieved compliance with the software and quality requirements of the pharmaceutical industry and health authorities
Pharmaceutical Trials in Latin America Supported by the DIA
Sparta Systems Announces Software for Electronic Submission of Medical Device Reports to Food and Drug Administration (FDA)
Introducing BMG LABTECH’s new OMEGA family of microplate readers
Ingenia scoops Global Security Challenge award
Camera Phone can identify counterfeit products worldwide: another first from AlpVision SA
New Simplicity® System from Millipore. Provides Ultrapure Water When and Where You Need It
Alberto Frausin takes the helm of Zambon Group's pharma business
FDA Approves New Treatment for Gastrointestinal and Kidney Cancer
Agilent Technologies Upgrades Cerity CDS for Pharmaceutical QA/QC
ICON Supports Amarin's European Pivotal Phase III Clinical Trial
FDA GRANTS REVLIMID® NDA APPROVAL
RTS Installs Second Clonal Cell Line Expansion System
Astech Projects launches the new Tablet-Pro
Press Release: Solvay Organics at the CPhI 2007 - Custom synthesis of active ingredients, building blocks, peptides and oligonucleotides
Axxom Software AG Exhibits at SAPPHIRE® ’07 Vienna
ISPE-PCC Awards First CPIPSM Credential for Industry Professionals
     
 
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.

For more information visit our website
www.multipharma.ch or email info@multipharma.ch.

Contact: Kay-Christian Karstadt
Phone: +49 30 250 40 72 0
Email: kay.karstadt@multipharma.de

 
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.

For more information, please visit www.infratrac.com.

CONTACT:
David Forbes

InfraTrac, Inc.
Phone: 202-251-4648
Fax: 301-589-9443
pr(at)infratrac.com
www.infratrac.com

 

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.
 

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 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."

Contact:
Brendan Mulgrew / Carl Whyte
Stakeholder Communications
02890 339949 / 07767 393252

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.
  
To find out more about Almac visit www.almacgroup.com

 

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.
 

Media Inquiries:

DHL Press Office
T +44 (0) 207 413 3332
luke.baines@hillandknowlton.com  


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.

www.dhl.co.uk

 

 

 
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.

 

Media Inquiries:
DHL Press Office
T +44 (0) 207 413 3332
luke.baines@hillandknowlton.com

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.

www.dhl.co.uk

 

Key Almac division celebrates 20 years of growth

 

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.

To find out more about Almac visit www.almacgroup.com.

 
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.

 

For more information, please contact:

Mats Norell 
Sales Manager Stralfors Pharmaceutical
Stralfors Pharmaceutical & Healthcare
Tel: +46 706 15 10 74 
E-mail: mats.norell@stralfors.se  
   
Elin Johnsson
Marketing Coordinator
Stralfors BA Labels       
Tel: +46 706 85 06 95    
E-mail: elin.johnsson@stralfors.se

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.  

 

For more information, please contact:

Hanne Wartenberg 
Sales Manager Stralfors Pharmaceutical DK
Stralfors BA Labels 
Tel: +45 4090 2052 
E-mail: hanne.wartnberg@stralfors.dk  
   
Elin Johnsson
Marketing Coordinator
Stralfors BA Labels       
Tel: +46 706 85 06 95    
E-mail: elin.johnsson@stralfors.se

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

e-mail marketing.informatics@thermofisher.com

or register on-line at www.tiw08.com.

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”.



More information on can be found at www.pschem.com
www.chemtec-leuna.de
www.minakem.com
and www.minasolve.com.
 
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.”

For more information, please visit www.greenboxsystems.com
or www.sca-cool-logistics.com

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.

Contact



Vetter Pharma-Fertigung GmbH & Co. KG
Suzan Frohmann
Schuetzenstrasse 87
D-88212 Ravensburg
Phone: +49-(0)751-3700 - 0
Fax: +49-(0)751-3700 - 40 00
E-mail: info@vetter-pharma.com
www.vetter-pharma.com
 
Boehringer Ingelheim Chooses IDBS’ PredictionBase
 
 
 
For a high resolution image please contact nickim@alto-marketing.com
   

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.

Contact
Vetter Pharma-Fertigung GmbH & Co. KG
Suzan Frohmann
Schuetzenstrasse 87
88212 Ravensburg
Phone: (0751) 3700 - 0
Fax: (0751) 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.

 
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’s U.S. subsidiary Launches New Website www.pharamarama.com to Highlight
Firm's Global Expertise in Comparator Trial Supply and Named Patient Programs
 
Borehamwood, U.K. -- January 08, 2008 -- Pharmarama, a leader in the procurement of pharmaceutical products for comparator trials and named patient programs, today announced the launch of its new corporate Website at www.pharmarama.com.

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.

For more information, please visit us on the Web at www.pharmarama.com or www.brpharmaltd.co.uk.
 
Carrying on a tradition for more than 65 years
 

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. 

     
Sparta Systems Announces Software for Electronic Submission of Medical Device Reports to Food and Drug Administration (FDA)
     

Holmdel, NJ - February 20, 2007 – Sparta Systems, Inc., (Sparta), the maker of TrackWise®, and the market leader in enterprise quality and compliance process management software, today announced that it has released the Beta version of the TrackWise eMDR Submission Manager™ software. The add-on software enables medical device companies to electronically submit Medical Device Reports (MDRs) to Food and Drug Administration (FDA). TrackWise eMDR Submission Manager™ is one component of Sparta's current initiative to support the growing number of life sciences electronic submission processes, which are complementary to quality and regulatory solutions.

Medical device manufacturers use TrackWise to electronically track and manage product complaint and adverse event assessment and reporting processes. The software enables device companies to effectively manage complaints and investigations, assess potential adverse events for safety risk problems, and comply with health authority reporting requirements, including those of FDA.

FDA regulations require firms who have received complaints of device malfunctions, serious injuries, or deaths associated with medical devices to notify FDA of the incident. Manufacturers are required to submit an individual adverse event report (known as a "MDR Report") to FDA using its 3500A form. TrackWise customers currently produce 3500A reports in electronic form, from structured audit-trailed data fields. Sparta's 3500A report has been previously approved by both FDA's Center for Devices and Radiological Health (CDRH) and Center for Drug Evaluation and Research (CDER).

In an effort to streamline reporting of 3500A reports, FDA is now implementing an electronic submission program called "eMDR." Under this program, FDA receives electronic submissions of MDRs via the FDA Gateway, a secure agency-wide entry point for all electronic submissions. Using this approach, medical device manufacturers can issue their reports electronically, eliminating costs and errors associated with paper-based reporting processes.

 

Sparta was asked by FDA to participate in its eMDR pilot program. Collaborating closely with the agency, Sparta has developed standard functionality within TrackWise that allows customers to electronically transmit MDRs through the FDA's Secure Gateway.

"FDA's eMDR Program and the TrackWise eMDR Submission Manager enable our medical device customers to improve their adverse event reporting processes by eliminating paper forms and manual document routing," stated Mike Jovanis, Director, Solutions Architecture of Sparta. "TrackWise increases efficiency while approving accuracy of information, providing a better and more effective product safety process, which ultimately benefits consumers and patients."

The new functionality, TrackWise eMDR Submission Manager can be added to both existing and new TrackWise deployments. Several of Sparta's larger device clients are already working with Beta versions of the functionality, and are planning to begin submitting MDRs electronically upon completion of the beta program.

About Sparta Systems

Sparta Systems, Inc. is the industry leader for enterprise process management solutions. Its product, TrackWise, is used by over 200 companies to ensure compliance, improve control, reduce risk, and lower costs by consolidating management of issues and actions, automating workflow, and facilitating trending and reporting. Sparta Systems offers more than 12 years of experience. Additional information about Sparta Systems and TrackWise® can be found at www.sparta-systems.com.

     
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

Email: sales@bmglabtech.com
Website: www.bmglabtech.com
     
Ingenia scoops Global Security Challenge award
     

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.

  Camera phone

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.

 

Simplicity systemThe 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
  George Demetri, MD, Dana Farber Cancer Institute, Boston, USA
   
  Robert Motzer
  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 and strictly audited throughout their entire expansion process. The barcode on the plate is read by the system and the appropriate refeeding or expansion protocol selected. Either a proportion of the medium is removed and replaced, or the cells are diluted with medium and expanded into a larger number of wells. The plate is returned by the system to its incubator prior to a further inspection after several days. The growing cells move through the system until all 24 wells contain confluent cells. In the second of the two systems, further expansion of the cultures for cryostorage and DNA extraction is facilitated by transfer of culture from 24 well plates to six well plates.

The RTS systems at Bristol University are capable of handling up to 600 cultures at any one time, with inspections taking place during office hours and expansion and cell feeding taking place overnight. On average, there are now 2,400 culture manipulations each week.

Both systems have the capacity for automated plating out, re-feeding, well assessment (via automated ‘visual’ assessment or ELISA assay) and cherry picking of wells for expansion. Enclosing the system within a class II environment means that a range of applications such as Hybridoma production, vaccine development, DNA banking, Caco2 plate production and assaying may also be fully automated.

Notes
The RTS Group specialises in providing software, automation systems and equipment for a range of sophisticated manufacturing and scientific processes, including: nuclear engineering, life sciences and industrial automation. Deploying unique technologies to meet client specific requirements, RTS utilises state-of-the-art technology, products and know-how alongside proven engineering practices to provide the optimum automated solution. Extensive industrial and scientific experience exists throughout the Group and the Company operates globally, with facilities throughout the UK and the US.

All company product or service names mentioned may be trademarks or service marks of others.

Web Sites:
www.rts-group.com
www.rtslifescience.com

     
Astech Projects launches the new Tablet-Pro
     

Astech Projects launches the new Tablet-Pro, a revolutionary Tablet Processing system for drug content analysis at IBLA, Olympia, UK (November 15-16). Tablet-Pro's unique design gives it the ability to fully automate content uniformity testing and stability analysis, leading to higher throughput rates than ever before.

Anthony Moran, Astech's Business Development Manager explains "current industry expectations are 1 tablet every 30 minutes, creating backlogs in batch testing, this is often accompanied by vessel size restrictions." Anthony continues "Tablet-Pro offers a market-leading throughput restricted only by the number of modules. Improved scalability allows users to specify the number of homogenisers, vessel size and volumes for dissolution."

Astech are renowned for their superiority in bespoke design and engineering quality and the Tablet-Pro is no exception. Long term reliability is conferred through robust, high spec robotics and design excellence. Together with dependable reliability, running costs are also reduced by a novel filtration system which removes the need for expensive consumables. Tablet-Pro's advanced, easy-to-use software supports parallel processing functions for high throughput and is fully compliant with 21 CFR Part 11 and Good Automated Manufacturing Practice (GAMP).

Every aspect and detail of Tablet-Pro has been designed to meet the individual needs of the user and key areas of the system to suit their requirements and budget . Tablet-Pro's flexibility means it can be integrated with Liquid Chromatography (LC) systems and Chromatographic Data Systems (CDS) for automated analysis of samples. Tablet -Pro can also be further integrated with proprietary stand alone tablet testing systems to provide a complete automated solution.

 

The Tablet -Pro complements Astech's automated inhalation and regulatory respiratory technology, adding to their portfolio of highly automated drug delivery equipment.

www.astechprojects.com

About Astech Projects
Established in 1995 Astech Projects specialise in the development and supply of advanced automated system solutions. Leaders in innovative design Astech provide bespoke automation solutions designed and tailored to suit each customer's individual requirements. With an enviable portfolio of blue chip clients, Astech's areas of expertise range from pharmaceutical development and life sciences to the nuclear and petrochemical sectors.

With such a wide range of specialist knowledge and expertise Astech are fast becoming renowned in their field for their high quality bespoke solutions and tailor-made products. Astech is made up of a highly proficient team that boasts fine-tuned skills for the development of technologies and associated software solutions. These include the areas of laboratory automation, high throughput systems, data management, sample tracking, compound storage and retrieval, process control, special manipulators and decommissioning systems. Astech also offer individual consultancy services with in house disciplines including, project management, mechanical engineering and design, electrical engineering, control engineering and software engineering.

     
Press Release: Solvay Organics at the CPhI 2007 - Custom synthesis of active ingredients, building blocks, peptides and oligonucleotides
     
  George Demetri
  Working under cGMP conditions, Girindus undertakes the contract manufacture of active ingredients and intermediates for long-term commercial use.
   
  Robert Motzer
  Peptisyntha operates from two locations with Peptisyntha S.A. in Brussels, Belgium (foto) and Peptisyntha Inc. in Torrance, California.
   
 
  Solvay develops and tests fluorinated building blocks at its Hannover Technical Unit.

Solvay Organics at the CPhI 2007:
Custom synthesis of active ingredients, building blocks, peptides and oligonucleotides

15th August 2007. The Solvay Organics stand at CPhI 2007 will be presenting peptides, oligonucleotides and fluorinated building blocks, as well as offering process development, scale-up and custom synthesis of active ingredients. Experts from Application Technology, R&D and Production will be on hand at Stand L96 in Hall 11 to provide answers to technical questions in person.

Fluorinated building blocks
About 50 percent of all newly developed drugs and 20 percent of agrochemicals contain fluorine. For example, molecular groups such as CF3 and CF2 increase lipophilicity, which, in turn, boosts the ability of molecules to cross cell membranes. In effect, substituting C-H for C-F improves metabolic stability and slows down drug metabolism. Both the improved bioavailability and the greater stability enhance the efficacy of active substances. The change in molecular charge distribution caused by fluorine may also lead to a completely new action of a drug.

However, it is not easy to introduce fluorine into target structures because fluorination reagents are highly reactive, often explosive and can be harmful to the environment. Their use also requires highly specialist expertise and engineering technology. Moreover, fluorination reactions generally cannot be scaled up from laboratory to industrial production. It is much more economical and effective to incorporate fluorine into target structures in the early stages of development with the aid of building blocks.

At CPhI, Solvay Organics will therefore be presenting a whole range of fluorinated – particularly aliphatic – building blocks, including esters, ketones and acrylates. In addition, application technologists with practical experience will assist interested parties and are happy to discuss issues including the use of highly innovative, chiral building blocks.

Oligonucleotides and peptides
Oligonucleotides and peptides can have a targeted effect on the body’s cellular functions and open up a number of treatment options. The technologies for their use and production are still new and therefore require a great deal of expertise. For example, typical oligonucleotides such as 20-base DNA and RNA fragments require about 100 chemical reactions.

  At the CPhI, the company Girindus AG, majority-owned by Solvay, is focusing on therapeutic DNA and RNA oligonucleotides with all relevant modifications – for example phosphothioates, 2’-modified RNA or PEG conjugates. As a leading manufacturer, Girindus AG will be present at the Solvay-Organics stand to share their knowledge and provide information about production capacities at the American plant in Cincinnati and the German plant in Künsebeck. Large-scale production under GMP conditions uses both solid phase synthesis and a newly developed liquid phase synthesis process.

Peptisyntha, a subsidiary of Solvay Organics, offers production capacities for therapeutic peptides, together with developmental expertise. Eptifibatide is a good example of Peptisyntha’s capabilities.  A cyclic heptapeptide with a disulphide bridge, Eptifibatide is the active ingredient of Integrilin®, an anticoagulant used in heart surgery. Peptisyntha has successfully scaled up the manufacturing process under full cGMP conditions.  

From bench to market: process development, scale-up, manufacture
Girindus offers a range of technology, expertise and equipment for process development to pharmaceutical and cosmetics companies which have developed an active ingredient and wish to bring it from the laboratory to the market. These include reactions which take place under special process-technology conditions such as high pressure or extreme temperatures, as well as demanding synthesis techniques such as nitration, hydration or Suzuki coupling. The company can produce active ingredients and intermediates at virtually any scale – whether in laboratories, technical units or production plants. This is including production under cGMP conditions for long-term commercial use.


Background: Solvay Organics
Solvay Organics is part of the Solvay Chemicals Strategic Business Unit and specialises in organic molecules for a wide range of uses. Innovative molecules, materials and solutions are designed to help clients develop new applications. The main areas of operation are fluorinated building blocks, peptides and oligonucleotides, as well as process development and custom synthesis. The Solvay Group employs about 30,000 people worldwide.

www.solvay-organics.com
www.girindus.com
www.peptisyntha.com


The CPhI in brief
2 to 4 October 2007
Milan
Solvay Organics: 11L96

Customer Contact
Girindus AG - Member of Solvay Organics
Dr. Peter Markus
Buchenallee 20 / 51427 Bensberg (Cologne)
Tel. +49-2204-926947
Fax +49-2204-92693047
pmarkus@girindus.com

Media Contact
Solvay Management Support
Dirk Schulte
Hans-Böckler-Allee 20 / 30173 Hannover
Tel. +49-511-857 3799
Fax +49-511-857 2305
dirk.schulte@solvay.com
     
Axxom Software AG Exhibits at SAPPHIRE® ’07 Vienna
Accelerate your business by integrating SAP® applications with ORion-PI® 
     

Munich, April 27th 2007 – From May 14th to 16th 2007 Axxom Software AG will showcase its solution portfolio based on SAP® applications at SAPPHIRE® ‘07 Vienna. In line with the fair’s motto “Business at the Speed of Change” the German technology company will present solutions which help companies to turn the accelerated global changes into their own competitive edge. All Axxom modules presented in hall B / booth 2.3 work as add-on and can easily be integrated with SAP applications via a special tool called ORion-PI® Direct Link to SAP Applications. Focus of the exhibition rests on the following planning and optimization approaches: solutions for the strategic planning & optimization of production and logistics networks, modules for the optimization of logistics processes and a demand-oriented workforce management and advanced planning systems for detailed scheduling. Those interested are invited to take a closer look at project scenarios of leading users of SAP applications.

„Axxom’s entire planning and optimization portfolio can be easily integrated with SAP applications. SAPPHIRE ’07 Vienna thus is the ideal platform to introduce the advantages of an easy integration of their SAP applications with our planning and optimization systems. No matter if strategic or operative, if in production or logistics, with ORion-PI® Direct Link to SAP Applications we guarantee a fast and easy exchange of data between SAPapplications and our solutions.” stresses Dr. Christoph Plapp, Manager of the Board at Axxom Munich.

The solutions showcased at SAPPHIRE ‘07 Vienna can be divided in four major application areas:

“On top of” SAP   applications: modules for the strategic planning & optimization of production and logistics networks

ORion-PI® Value Network Optimization is an integrated solution for the design, simulation, planning and optimization of network scenarios and value-added processes relevant to production and logistics.

The ORion-PI® Business Planner supports strategic capacity planning and the simulation of business scenarios. It helps to optimize batch sizes and inventories (working capital) across all process steps of the supply chain.

SAP  applications “plug-in“: Solutions for the optimization of logistics processes, integrated with the logistics portfolio of SAP LES/EWM or SAP PP via ORion-PI® Direct Link to SAPapplications

The portfolio contains modules for the simulation, for order batch optimization, order sequencing and pick process optimization, for the generation of „Golden Cartons“, for replenishment, the optimization of carton sizes and carton filling.

 

SAP software “add-on”: solutions for a demand-oriented workforce management in production and logistics, based on mySAP™ ERP HCM

ORion-PI® Demand-oriented Workforce Managementis a comprehensive module for the planning and optimization of short-, mid- and long-term personnel capacities which is oriented along the actually prognosticated need. The solution can, among others, be used to optimize shift patterns or to balance in-house staff and temporary workers.


SAP applications “add-on”: APS system for operative planning, complementing SAP PP and SAP PP-PI, respectively mySAP SCM

ORion-PI® offers company, as well as industry specific planning solutions, supporting e.g. sequence planning, capacity utilization or manufacturing control. It accounts for cycles in the material flow, for by-products, available personnel or sequence and attribute dependant cleaning/set-up.

Profile Axxom Software AG
Axxom Software AG is an international provider of software solutions developed for the comprehensive optimization of value-add processes. With its software ORion-PI® the technology company offers a solution for the design, simulation, planning and optimization of all business processes in distribution, logistics and production. Among its customers there are leading manufacturers and suppliers from the automotive, chemical and pharmaceutical industries as well as businesses from the logistics, shipping and distribution sector. Axxom’s headquarters are in Munich, Germany. The company has a sales branch office in Cork/Ireland as well as a development and support centre in Timisoara/Romania.

Further information for journalists:
Axxom Software AG
Julia Haigis
Corporate Communications
Paul-Gerhardt-Allee 46
81245 Munich
Tel: +49 (0)89 /  568 23-377
Fax: +49 (0)89 / 568 23-399
E-Mail: julia.haigis@axxom.com
Internet: www.axxom.com  
                 

** SAP, SAPPHIRE, SAP NetWeaver and mySAP are trademarks or registered trademarks of SAP AG in Germany and in several other countries.



   
ISPE-PCC Awards First CPIPSM Credential for Industry Professionals
     

Brussels, 28 August 2007 – The first international Certified Pharmaceutical Industry Professional (CPIP SM) credential – made available through the ISPE Professional Certification Commission (ISPE-PCC) – has been awarded to four industry professionals, announced ISPE-PCC today.

This new credential offers the first competency-based international certification for pharmaceutical professionals and is helpful to the pharmaceutical industry in general by qualifying professionals to a global competency standard through demonstrated education, experience, and a rigorous examination.

The following individuals have been conferred the CPIP:

  • Mr. Anders Brummerstedt, CPIP,  Manager of Computer Systems Quality, NNE Pharmaplan, Soeborg, Denmark
  • Mr. Andrew A. Signore, P.E., CPIP, CEO, IPS, Lafayette Hill, Pennsylvania, USA
  • Mr. Damian Gerstner, CPIP, President, sys-tek, Blue Springs, Missouri, USA
  • Ms. Tiffany G. Tomlinson, CPIP, Manufacturing Manager, IDEXX Pharmaceuticals, Inc., Greensboro, North Carolina, USA

“We are pleased to bring this credential to the industry,” said Jerry Roth, P.E., Director of Professional Certification. “It supports the U.S. Food and Drug Administration’s acknowledged need for change within the pharmaceutical industry to improve drug product safety and quality and consumer cost effectiveness. We are delighted that ISPE can continue to be a catalyst for change and help move the industry forward.”
Already, the CPIP credential is hailed by industry leaders as beneficial to team leaders, allowing them to qualify project teams and support ongoing professional development. To learn more about the credential and how to apply for eligibility, visit www.ispe-pcc.org.

 

About ISPE

ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for 25,000 pharmaceutical manufacturing professionals in 90 countries around the globe. ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida, U.S.; its European office in Brussels, Belgium; and its Asia Pacific office in Singapore. Visit www.ispe.org for additional Society news and information.

About the ISPE-PCC
The ISPE Professional Certification Commission (PCC), an autonomous governing body within ISPE, develops certification programs to benefit credential holders and their employers, as well as government, academia, and the public health product consumer. The PCC is composed of 12 Commissioners: senior-level industry professionals representing Argentina, Australia, Japan, North America, and the United Kingdom, as well as academia, the US Food and Drug Administration (USFDA), and the general public. Visit www.ispe-pcc.org for additional certification information.

For further information please contact
Gazelle Gaignaire
ISPE European Office,
Marketing and Communications Manager
Brussels
tel: +32 2 743 4422
email gazelle@associationhq.com