Robust, Load Independent Viral Clearance in Monoclonal Antibody Purification

Anion exchange chromatography is an important flow-through polishing step for viral clearance of monoclonal antibodies. Resin based materials are most commonly used for this but the large size of virus particles limits diffusion and binding capacity. It is therefore necessary to use large volumes of resin and oversized column hardware. Column chromatography as a unit operation also means high operational costs, including validation, cleaning and storage. This is a particular issue for clinical manufacturing, where a column is used for only a fraction of its useful life.

The single-use NatriFlo® HD-Q anion exchange membrane adsorber provides a simple, cost-effective and robust solution for final polishing and viral clearance of monoclonal antibodies, with far greater productivity than modern resins. One NatriFlo HD-Q device can replace a chromatography column that is up to 80 times larger. For example, the 460 ml NatriFlo P600 HD-Q device can replace chromatography columns up to 40 liters.

This paper highlights the superior viral clearance capabilities of the NatriFlo HD-Q membrane adsorbers by studying the clearance of the most difficult virus, MVM, over a wide design space. The paper also demonstrates that HD-Q showed effective removal of three other viruses: xMuLV, PRV and Reo-3.