In Bioprocess Development [top]: A Mab A Case Study

Transitioning from 10L benchtop vessels to 2,000L production bioreactors required precise control of dissolved oxygen (DO), pH, and temperature. For mAb A, a fed-batch strategy was implemented, where concentrated nutrients were added periodically to extend culture longevity and maximize final product concentration. Phase 2: Downstream Processing – The Art of Purification

During the low pH elution step (0.1 M sodium citrate, pH 3.5), the aggregation issue flagged earlier emerged. Mab-A formed 15% aggregates post-elution. A Mab A Case Study In Bioprocess Development

The primary purification step utilized Protein A affinity chromatography. This resin binds specifically to the Fc region of mAb A. While highly effective, Protein A is expensive. The case study focused on optimizing "residence time"—the duration the fluid stays in the column—to maximize binding capacity and reduce resin costs. Viral Inactivation and Polishing Transitioning from 10L benchtop vessels to 2,000L production