Understanding Viral Clearance During Anion-Exchange Chromatography: A Novel Design of Experiments Approach

Anion-exchange (AEX) chromatography is a well-established polishing step for removal of viruses and other impurities during downstream processing of biotherapeutics. Before initiating phase 1 clinical trials, a representative scaled-down model of the final process must be available for use in viral-clearance studies. At that point, however, scientists usually have no way of knowing how effective a process will be for removing viruses.

In this article, scientists from Thermo Fisher Scientific and Bristol Myers Squibb (BMS) describe their efforts to define mechanisms of virus removal during a polishing step based on POROS HQ chromatography resin (Thermo Fisher), a strong anion exchanger.

Download the article to learn about the team’s design of experiments (DoE)-based study of minute virus of mice (MVM) removal from three monoclonal antibody (MAb) products of different biophysical properties. Results from the POROS HQ resin study shed light on the biopharmaceutical industry’s movement toward mechanistic understanding of viral clearance during AEX chromatography processes.

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