(342e) Overload and Elute Chromatography for Enhanced MAb Purification

Bio-pharmaceutical process development has increasingly been relying on platform processes that reduce development timelines and time to clinic. However, certain MAbs may not fit into the platform process thus requiring further development. This talk will focus on a set of MAbs that bind to the anion exchange (AEX) resin under flow-through conditions. To enable plant fit, improve yield and achieve adequate impurity clearance, a novel mode of chromatography was developed with a multimodal resin.  The resin was operated in an overload mode with a step elution enabling significantly higher load density while obtaining the desired impurity clearance. Data on clearance of model viruses, host cell proteins and aggregates will be presented. High throughput screening was employed to rapidly identify process parameters for overload and elute chromatography. Data generated to develop a mechanistic understanding of product and impurity binding to the resin under the overload and elute mode of chromatography will also be presented.