Liaison(s): Daniel Celic, Arch Creasy, Leo Kutlowski, Cindy Wu
Pfizer is a leading global producer of pharmaceutical and biological products throughout the life sciences industry. Founded in 1849, Pfizer has become a market leader in manufacturing and supplying small molecules, biologics, and vaccines around the globe. Pfizer primarily serves the biopharmaceutical market. Pfizer is in the process of optimizing a downstream bioprocessing platform for the purification and polishing steps of a monoclonal antibody (mAb)-like molecule. Several new molecular antibodies like the mAb-like molecule are at different phases of regulatory approval. However, to leverage Pfizer’s investment in this product, Pfizer would like to explore alternative routes of purifying and polishing the mAb-like molecule. The Pfizer Protein Modeling Chromatography TMP team was tasked with the optimization of downstream purification processes using a mechanistic modeling approach. To accomplish this, the Pfizer TMP team collaborated with Pfizer liaisons to generate in silico, digital twin models of real-world purification processes. By using lab-generated data, the team ran and optimized computer-generated iterations of these experiments to best match the computer-simulated data to real-world data. By doing this, the Pfizer TMP team will help validate a model which is a necessary step in Pfizer’s lab process qualification studies. After defining appropriate control parameters and strategies with this model, Pfizer could leverage the model in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines for use in biologics license application regulatory filings.