LOOKER_STUDIO
–
STOCK.ADOBE.COM
22 Pharmaceutical Technology
®
|
BioPharm International
®
Bio/Pharma Outsourcing Innovation February 2025
P
rocess development is a key factor in the de-
velopment and manufacture of biologics. Pro-
cesses must be developed and validated so that
product specifications can be met to create a
safe and effective biologic drug. Contract development
and manufacturing organizations (CDMOs) offer spon-
sor companies the expertise to develop these processes,
which then must be validated. Process validation is a
necessity to be sure the manufacturing process pro-
duces the desired, safe product.
Process characterization
For cell culture processes, process validation must
be performed before good manufacturing practice
(GMP) batches can be produced for early phase pro-
duction, according to Daniel Giroux, vice-president
of Biologics Development at Abzena. Formal process
character studies must then be performed before
commercial production so that one can understand
t he impact of variations f rom target parameters.
Small-scale studies are performed on a validated
scale-down model, and the information obtained is
then applied to large-scale production.
"You need to understand what are allowable ranges
and what will have an impact on your process or on
t he product qua lit y, and t hose [parameters] t hat
won't [have an impact]. [Therefore,] you divine your
process envelope …the combination of all these pa-
rameters, such as agitation, temperature, feed timing,
feed amounts, and so on. [These are] design-of-ex-
periment approaches, because you have to measure
[the parameters] impact, both individually, as they
change, but also when they change in combination,"
says Giroux.
After process characterization and studies are per-
formed and acceptable ranges established, batch re-
Characterization and
Qualification of Processes
Susan Haigney
Contract manufacturers have special expertise in the
characterization and validation of biopharmaceutical manufacturing processes.
