Scaling Rapid Cycling Membrane Chromatography From Bench To Commercial Manufacturing

By Mario Gruenberg, Karolina Meyer-Heinrichs, and Jonas Triebe

The goal of this study was to demonstrate the successful scale-up of a rapid cycling chromatography (RCC) process from a generic bench chromatography system to the Resolute® RCC MU and Resolute® Flowdrive SU using the Sartobind® Rapid A as the chromatographic matrix of choice. The results demonstrated scalability with no significant loss in product yield or quality. Combining high productivity chromatography methods and SU affinity membranes deliver a viable alternative to the current packed bed Protein A capture techniques for intensified purification of monoclonal antibodies (mAbs) up to commercial production scale.