Robust, Load Independent Viral Clearance In Monoclonal Antibody Purification With Natrix® Q Chromatography Membrane

Anion exchange chromatography is an important flowthrough polishing step for viral clearance of monoclonal antibodies (mAbs). 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. Cost efficiency of over-sized resin columns can only be achieved through amortization, which also means high operational costs, including cleaning and storage in between batches, and associated validation, quality testing and documentation requirement. This is a particular issue for clinical manufacturing, where a column is used for only a fraction of its useful life so cost efficiency of the investment is compromised.

The high functional group density and open structure of the Natrix® Q chromatography membrane overcome these limitations in virus clearance to enable a right-sized, single-use per batch solution with improved cost efficiency. In this study, its performance in the removal of 4 model viruses is measured across a range of pH, conductivity, and buffer systems.