Continuous Chromatography In Downstream Processing Of A Monoclonal Antibody

In this study, periodic counter current (PCC) chromatography and straight-through processing (STP) technologies were evaluated in a continuous three-step monoclonal antibody (MAb) purification process. MAb capture was performed using MabSelect SuRe™ LX protein A chromatography medium (resin) in a three-column PCC (3C PCC) setup on the ÄKTA™ pcc 75 chromatography system. To assess robustness of the setup, 10 cycles were performed. The results showed consistent yield and purity over time. Using the 3C PCC setup, the capacity utilization could be increased by 56% as compared with an equivalent batch run.

The capture step was followed by two polishing steps in an STP setup on the ÄKTA pure chromatography system. Capto™ S ImpAct and Capto adhere media in serially connected columns with an intermediate in-line conditioning step were used. Two setups were evaluated, where the first Capto S ImpAct polishing step was run in either bind-elute (B/E) or flow-through (FT) mode. The second Capto adhere step was performed in FT mode in both setups. Results from both setups showed similar yield and purity as what can be expected from a traditional setup performed in batch runs.