The Development and Application of a Monoclonal Antibody Purification Platform - A purification scheme to maximize the efficiency of the purification process and product purity while minimizing the de

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The Development and Application of a Monoclonal Antibody Purification Platform
A purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies.


BioPharm International Supplements


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,

References

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