Summary
The antibody purification platform process used in Pfizer's Global Biologics organization has undergone changes over the years
in response to increases in both production scale and cell culture titers. These changes have resulted in a purification scheme
that takes advantage of previous knowledge to reduce development time, while ensuring that product purity and virus clearance
are sufficient for clinical manufacture. The goal is to manufacture early-phase material without having to perform downstream
development, and the current process as outlined in Figure 1 is capable of meeting that goal. However, further increases in
titer will likely bring more challenges, and thus it will be necessary to implement additional modifications to our process
to keep pace with increasing upstream productivity.
Acknowledgements
We would like to acknowledge the entire purification group in Global Biologics for their help, as well as the cell culture
groups for their provision of the cell culture broth necessary to complete these studies. In addition, these studies would
not have been possible without the support of the process development analytics group.
JUDY GLYNN is senior principal scientist, TIMOTHY HAGERTY is scientist, TIMOTHY PABST, PhD, is senior scientist, GOPINATH ANNATHUR is senior scientist, KRISTIN THOMAS is senior scientist, PAUL JOHNSON is scientist, and NATARAJAN RAMASUBRAMANYAN, PhD, is an associate research fellow, and PAUL MENSAH, PhD, is an associate research fellow, all at Pfizer Global Research and Development Global Biologics, Bioprocess R&D, Chesterfield,
MO, 636.247.6519, judy.k.glynn@pfizer.com
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