Keys to commercial success
The commercial canyon in biopharmaceutical early
development can be found between the
laboratory bench and clinical trials; however,
with a consolidated approach, firms both small
and large can bridge the gap. Adopting Patheon’s
four key strategies can make a difference.
Patheon has spent 30 years providing contract
dosage-form development and manufacturing services
to the pharmaceutical industry. It follows four
key
strategies that help build success into biopharmaceuticals.
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SGS offers a comprehensive
range of life science services. |
Face today’s challenges without creating
new ones After years developing a biologic, it
is often jarring to shift gears into the development
of the pharmaceutical product. New challenges
your team will face include inherent instability,
light and temperature sensitivity, and cold chain
logistics.
Meanwhile, business pressure to get the product
through
clinical trials and out to market is immense.
Pragmatic choices need to be made about highly
complex
science to obtain a suitable formulation quickly.
These choices
have the potential to take time and cost a lot
of money. What you
need is expert advice, so it is wise to engage
your centralised
data management office (CDMO) early. While you
want to be
efficient, you need to know that you can manufacture
what you
develop and safely administer it to patients in
clinical trials.
Formulation technologies
The goal is to find the best way to take what
you have in the
lab and deliver it intact to patients. To accomplish
this you
must explore as many suitable formulation options
as time and
budgets allow. No single analytical technique
is capable of
measuring all of the different types of degradation
to which a
biopharmaceutical is susceptible.
Find a CDMO that offers a broad range of options.
Ideally
they’ll have the capability to design an
early formulation that can
change between liquid or lyophilisation. They
should also be able
to manufacture at an appropriate scale to meet
clinical test
material requirements. And if they offer multiple
fill/finish options,
better still. Make sure you give your molecule
the broadest range
of options to enable it to become a viable product,
and don’t be
limited by a contractor with limited offerings.
Never underestimate the value of consistency
Formulation, analytical development and process
design are so
interrelated that it makes sense to consolidate
them under one
roof as much as possible. Transferring methods
and processes
from one contractor to another often causes costly
delays and
redundant revalidations.
Potential pitfalls include additional steps (and
missteps) in
communication, untimely response from former vendors,
and
differences in equipment; for example, cell-based
assays are
notorious for behaving in unexpected ways in different
laboratories. By adopting a consolidated approach
with a single
CDMO, you’ll be better able to optimise the
timing, achieve
smooth transitions from one stage to the next,
establish
streamlined channels for providing feedback and
addressing
concerns before they become problems, and maximise
limited
quantities of highly expensive early-stage biologic
material.
Team continuity is crucial. Having the same people
working
on various stages of your project will preserve
knowledge and
experience of complex methods. You also get to
maintain
momentum and build interpersonal relationships
– the most
difficult chemistry of all to master. The bottom
line: when you
minimise transfers, you minimise risk.
When choosing your CDMO choose experience
You should partner with an experienced CDMO in
order to
benefit from their scientific expertise and for
the depth of their
existing organisational capabilities and resources.
A contractor
with auditing preparedness, systematic record-keeping,
and a
stellar regulatory track record can help you avoid
unnecessary
delays. A CDMO with a broad client base typically
demonstrates a broad array of in-house capabilities
to satisfy
the needs of your product. It also indicates the
organisation has
the equipment to produce clinical test materials
in appropriate
quantities and to seamlessly scale up manufacturing.
A contractor that is financially stable will
be around to
complete the development cycle, and if your product
is a
commercial success, they will have the means to
scale up to
meet commercial demand and support you over the
long haul.
Not only is an experienced CDMO best able to
help you
bridge the gap from early development to formulation,
the
chances are it already has that bridge built and
waiting.
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