Senior CMC Project Manager, Vaccinex, Inc.
Oversight of contract manufactur- ing organizations (CMOs) pro- ducing proprietary drug substance
or drug product can be a daunting task,
especially for small biotech companies.
The manufacturing process for a biophar-
What is the Client’s Role?
maceutical is inherently complex; there
are typically hundreds of components,
numerous pieces of equipment with mul-
tiple operating parameters, and several
operators executing the bioreactor and
purification operations. Management of
these critical elements of the supply chain
is largely out of the client’s direct control
and rests in the hands of people in a dif-
ferent city, region or perhaps even a dif-
ferent country. Necessarily, sponsors must
rely on periodic project meetings or tele-
conferences for manufacturing campaign
updates to learn the status and timing of
the production operations. For many cli-
ents the relationship with the contract
manufacturer is mostly virtual.
However, because the stakes are very
high and there is little room for error
when manufacturing a biopharmaceuti-
cal product, a better approach to CMO
oversight would involve the client serving
as an active participant in the execution
of the campaign and rely less on periodic
updates via web/teleconference. Work-
ing together as a team on manufacturing
preparedness, the CMO and client estab-
lish lines of communication that wouldn’t
necessarily exist if the client took a hands-
off approach. In turn, this deliberate and
direct engagement decreases the risk of an
error or misunderstanding related to the
client’s production process at the CMO.
The client’s involvement provides an extra
level of review that could prevent a po-
tentially catastrophic failure leading up to
or during the manufacturing operations.
This thoughtful and proactive review of
the components and systems involved in
A look at the client’s role in ensuring manufacturing readiness for biopharma production
at a CMO