A straightforward methodology for designing continuous monoclonal antibody capture multi-column chromatography processes

摘要

A simple process development strategy for continuous capture multi-column chromatography (MCC) is described. The approach involves a few single column breakthrough experiments, based on several simplifying observations that enable users to rapidly convert batch processes into well-designed multicolumn processes. The method was validated using a BioSMB (R) (Pall Life Sciences) lab scale multi-column system and a mAb capture process employing Protein A resin. The approach enables users to optimize MCC processes based on their internal preferences and constraints without requiring any mathematical modeling expertise. (C) 2015 Elsevier B.V. All rights reserved.