Streamlined Polishing And Viral Clearance

By Jonathan Hester, Jennifer Heitkamp, Matthew Peters, Zona Jokondo, and Jerald Rasmussen

Flow-through anion-exchange (AEX) chromatography is used frequently in biopharmaceutical purification processes for reduction of net–negatively charged host-cell proteins (HCPs) and viruses as part of a validated viral clearance strategy. AEX column chromatography is the technology most often used for electrostatic viral clearance, particularly in commercial-scale  biopharmaceutical manufacturing, for which columns have a long-established history of reliable and well-understood performance. Still, validation of HCP and viral clearance by AEX columns in biopharmaceutical processes involves complexities that contribute significantly to operational and regulatory costs.

The introduction of single-use AEX technologies has illuminated the potential for reducing regulatory and operational costs associated with flowthrough AEX chromatography. The single-use AEX products benefit from improved specific capacity and enhanced flow rates compared with columns because diffusive kinetics have been replaced by convective flow.

In this paper we highlight the potential for substantial simplification of downstream polishing by replacing complex, buffer-hungry, condition-limiting AEX resin columns with simple, small-footprint, single-use chromatography devices.