Year: 2021-22

Company: Pfizer

Liaison(s): Arch Creasy, Jeff Salm, Daniel Celic

Pfizer, Inc. is a multinational pharmaceutical and biotechnology company first founded in 1849. Efforts by Pfizer are focused on core therapeutic areas including, chronic inflammatory and autoimmune diseases, vaccines, oncology, cardiovascular and metabolic disease and rare diseases. To support their drug pipeline over the years, Pfizer, Inc. has developed all the capabilities needed to bring their drugs to patients, from drug discovery to commercial manufacturing.

Monoclonal antibodies (mAbs) make up a large portion of Pfizer’s biologics portfolio. To enable accelerated development of mAbs, Pfizer uses a well-established platform purification process. However, due to the emergence of non-platform antibodies, there is a need for a 3rd non-platform chromatography step in order to remove product related impurities (High Molecular Weight Species, misfolded mAb, fragments), that are associated with these new class of molecules. This third chromatography step is usually Cation Exchange Chromatography (CEX) or Hydrophobic Interactions Chromatography (HIC). Pfizer is interested in shortening the optimization process of this polishing step by utilizing mechanistic modeling to predict chromatographic separation performance and productivity, based on limited experimentation.

The goal of this TMP is to obtain chromatographic and fractional analytic data for the molecules provided by Pfizer to predict the optimal operating conditions of CEX and HIC resins utilizing Cytiva’s GoSilico™ Chromatography Modeling Software. To obtain the necessary data, multiple chromatography runs must be performed via ÄKTA™ Pure with both resins and elution fractions being analyzed from each run via high-performance liquid chromatography (HPLC) size exclusion chromatography (SEC) and HIC. Running these models will allow Pfizer to quickly characterize complex chromatographic separations and develop robust downstream unit operations for clinical and commercial manufacturing.