Application Note

Robust, Load Independent Viral Clearance In Monoclonal Antibody Purification With NatriFlo® HD-Q Membrane Adsorber

Millipore Natrix

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. 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 high ligand density and open structure of the NatriFlo® HD-Q membrane adsorber overcome these limitations in virus clearance. In this study, its performance in the removal of 4 model viruses is measured across a range of pH, conductivity, and buffer systems.

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