26 Pharmaceutical Technology
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Bio/Pharma Outsourcing Innovation eBook February 2024 PharmTech.com
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W
orking with a contract development
and manufacturing organization
(CDMO) is a great way for smaller or
diversified biotech companies, and
even Big Pharma, to expand operations or modalities
to reach the patients more efficiently. Outsourcing
process development and manufacturing requires
a lesser upfront investment with faster timelines
while allowing teams at advanced therapy develop-
ers to focus on innovation. However, this relation-
ship can deeply impact the quality and efficacy of a
product. This article explores the balancing act of
ensuring regulatory compliance via internal proce-
dures at a CDMO and what to consider when starting
this relationship.
Quality in the contract
CDMOs will always have multiple customers, as this
is how t heir business model is bui lt. It can be an
uncomfortable position to seek a CDMO, particularly
for those coming from Big Pharma, where there is
direct quality oversight over processes. Looking for
a CDMO with a wide platform of tools that can be
tailored to meet regulatory compliance and both pro-
vider and customer pharmaceutical quality system
(PQS) requirements is important.
Un for t unately, many CDMOs of fer qua lit y pro-
cesses with minimal f lexibilit y for customers be-
cause t his is t he easiest for t he CDMO to control.
Doi ng t h is m i n i m i zes t he r isk s a ssociated w it h
customer specific variations to processes, reduces
costs for the CDMO, and is easier to defend during
inspections. However, this can lead to a disconnect
between the customer and the supplier.
When CDMOs develop quality agreements with a
greater focus on client needs, it can increase trust,
compliance, and even make audits easier to manage.
Complex procedures can be simplified by engaging
Ensuring Quality in
Contracted Support
Iain McGhee
is vice president of
Quality at Ascend.
This article looks at the relationship between a CDMO quality organization and the client.
