Higher titers and faster bioreactor turnaround times place increasing strain on the downstream process to efficiently purify our therapeutic proteins to drug substance, while maintaining high purity.   The growing appeal of continuous manufacturing has intensified this push for highly productive purification steps, particularly where operation of chromatography columns in flowthrough mode can be more readily adapted.  The body of work presented herein, focuses on the second polishing step that is currently designed for HMW removal, viral clearance, and trace impurity clearance.  A CEX resin, designed specifically for flowthrough chromatography, was compared against the existing no-salt flowthrough HIC process step with several different Mabs to identify opportunities to significantly increase mass loading, thereby increasing productivity and reducing cost and raw material consumption, while maintaining efficient removal of HMW species.

Evaluation of flowthrough CEX for increased productivity and efficient removal of HMW

ACS Spring 2022

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