In Silico Optimization Of A Multimodal Chromatography mAb Polishing Step

By Tobias Hahn, Nora Geng, Pia Graf, and Jennifer Reichert

Computer simulations are now indispensable in many industries, enabling improvements in productivity and faster innovation cycles. In biopharmaceutical processes, mechanistic modeling of chromatography as a tool for in silico process development has received increasing attention over the past decade, and its adoption is driven by increasingly straightforward modeling workflows.

Our industrial case study shows how process optimization for a mixed-mode chromatography polishing step for a monoclonal antibody can be achieved with only six calibration experiments resulting in a doubling of process productivity. The case study follows a generalized modeling workflow including the required experiments needed to calibrate a model.