Year: 2022-23

Company: Pfizer Inc.

Liaison(s): Arch Creasy, Jeff Salm

The purification platform for monoclonal antibodies (mAbs) has matured significantly and has now been successfully applied for the cGMP manufacture of numerous commercial mAbs. Many new mAb-like biopharmaceuticals, however, have recently been identified and typically require an additional non-platform chromatography step to remove product related impurities. Several examples of these non-platform molecules are next-generation bispecific and trispecific antibodies. These molecules tend to have elevated levels of high molecular weight species (HMMS), fragments, and homodimers that need to be removed. The standard platform purification process is often not sufficient to remove these product related impurities and may require an additional chromatography step. The objective of this project is to develop the procedures around collection of relevant data and selection of an appropriate model for fitting. The goal is to use a fitted model to predict chromatographic separation performance based on limited experimentation and speed up normal process development timelines.