www.biopharminternational.com March 2021 eBook BioPharm International 23
Overcoming Challenges to
Biopharmaceutical Development
and Manufacture with Science and
Risk-Based Strategies
Collaborative industry efforts address the safe handling of biologic drugs
in closed-system transfer devices and phase-appropriate specifications.
T
he ma ny c ha l lenges of biolog ic d r ug
development a nd ma nu fac t u r ing ca n-
not be resolved by a single company. Pre-
competitive collaborations have addressed
many shared issues, resulting in improved
processes to bring therapies to patients.
T he m ission of IQ C onsor t iu m B iolog ic s C M C
Leadership Group (Bio CMC LG) and its 10 working
groups (WGs) is to facilitate the identification of chal-
lenges that impede the development and/or commer-
cial manufacture of biologic products, and to propose
broadly applicable solutions to proactively advance
innovative, science-, and risk-based strategies.
Previous efforts have focused on comparability,
cell-line clonality, detection of sequence variants,
phase-appropriate specifications, subvisible particles,
and application of quality-by-design principles. In
2019, the LG identified emerging challenges: accel-
erated product development, global harmonization,
and data integrity.
Using the Consortium's platform (1), which enables
pre-competitive exchange of information, working
groups have addressed a variety of challenges being
Paulista
-
Stock.adobe.com
Saroj Ramdas, Renata Varga, Martin Gastens, Twinkle R. Christian, Bharat
Jagannathan, Barbara Rellahan, and Jillian Brady; all authors are members
of the IQ Consortium.
Regulatory Sourcebook Quality Collaboration