22 BioPharm International eBook March 2018 www.biopharminternational.com
Outsourcing Resources Process Validation
Process Validation in
Biologics Development
Process validation is an extension of biologics development processes.
SUSAN HAIGNEY
W
hen it comes to outsourcing process
validation of biologics, Abel Hastings,
d i r e c t o r o f p r o c e s s s c i e n c e s at
FUJIFILM Diosynth Biotechnologies,
says that the relationship between a
contract development and manufacturing organiza-
tion (CDMO) and sponsor is key in ensuring successful
process validation. "Customers that are open about
their strategy, their data (good and bad), and their
own strengths and weaknesses are most successful."
BioPharm International spoke with Hastings about the
specific challenges that arise in the process validation
of biologics.
CHALLENGES SPECIFIC TO BIOLOGICS
BioPharm: What are the challenges of performing process
validation during Phase III of biologics development?
Hastings: A primary challenge we see is viewing valida-
tion as phase-specific. Ideally, process validation should
be an extension of the development and refinement pro-
cesses. To support this, develop a long-term strategy for
implementing some of the validation-readiness tools in
simple versions early in development so that a transition
toward validation is less a change in course and more an
acceleration of the project.
BioPharm: What aspects of process validation should
companies focus on when preparing to submit a biologics
license application to FDA?
KUNST
BILDER/SHUTTERSTOCK.COM
