PharmaceuticalOutsourcingQ42020 - 11

INSIDER INSIGHT

2.	

3.	

4.	

Pick the right CDMO for the job. Just like each chemical
entity, each project is unique and will have its own
challenges, so it pays to work with a CDMO with the
experience and expertise to apply best practices it's learned
throughout the years to help boost your project's chance
for success. The key to reducing risk is to carefully vet
CDMOs before picking one and once you're comfortable
with its ability to move your project forward, you should
keep open the lines of communication between you and
your CDMO and work in partnership each step of the way.
Think carefully about cutting corners. Cutting corners
almost never saves you money in the long run. In fact, it can
add costs to your project when minor savings early on end
up requiring more work to occur in later stages when more
may be at stake. Listen to your CDMO's guidance about
where savings can and cannot be generated. For example,
it's often not a good idea to skimp in Phase 3 clinical
trials, which have a more than 50% chance of success. At
that point, there are clear clinical results, leading to solid
funding and a good chance you are on the right path to
commercialization. Yet, this stage of the process also means
greater scrutiny by the FDA and better odds of losing a
huge investment if any problems occur at this point.
Collaborate seamlessly. From optimizing synthesis routes
and developing methods and testing, to determining
packaging, delivery forms and dosage, there are a number
of scientific experts involved in the process. To ensure

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smooth operations, all stages should communicate with
one another seamlessly to share vital documentation,
history and information that can impact next steps.
5.	

Strategically vet raw materials suppliers. Quality raw
materials can result in molecules with less impurities,
which can significantly improve project timelines and
avoid cost and time over-runs. It's important to make
sure your CDMO has good sourcing relationships with
reputable suppliers, who not only provide materials of the
highest quality, but also those that have back-up suppliers
to ensure a steady supply.

6.	

Minimize the number of partners. When firms use multiple
CDMOs or contractors the more parties involved can
mean greater chance of errors or confusion. Further,
each time a CDMO works on a project, efforts might be
duplicated since each firm has its own Standard Operating
Procedures or strategy. Each time a project is handed
off from one firm to another, a lot of time is required for
effective project transfer.

Risk management in API manufacturing is crucial not only for the health
and safety of critical drugs, but also for the cost and time-management
consequences that can arise. Yet, carefully forming a sound regulatory
strategy at the outset of projects, collaborating across all stages and
trusting in your CDMO and its selection of suppliers, you can be on your
way to minimizing risk and setting out on the best route to success.

| October/November/December 2020
http://www.pharmoutsourcing.com
PharmaceuticalOutsourcingQ42020

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