18 BioPharm International
®
Partnerships for Outsourcing eBook May 2024 www.biopharminternational.com
W
orking with a contract development and
manufacturing organization (CDMO) is
a great way for smaller or diversied bio-
tech companies, and even Big Pharma, to
expand operations or modalities to reach the patients
more eciently. Outsourcing process development and
manufacturing requires a lesser upfront investment
with faster timelines while allowing teams at advanced
therapy developers to focus on innovation. However,
this relationship can deeply impact the quality and ef-
cacy of a product. This article explores the balancing
act of ensuring regulatory compliance via internal pro-
cedures at a CDMO and what to consider when starting
this relationship.
Quality in the contract
CDMOs w i l l a lways have mu lt iple c ustomers, a s
this is how their business model is built. 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.
Unfor tunately, many CDMOs of fer qualit y pro-
cesses with minimal f lexibilit y for customers be-
cause this is the easiest for the 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
all parties and clearly documenting in the quality
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.
J
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