Viral Contaminant Removal By Protein A Resin

Protein A based affinity chromatography is built into many downstream bioprocess platforms as an affinity capture step for GMP-certified biotechnology manufacturers’ monoclonal antibodies (mAbs) and mAb-related molecules such as Fc fusion proteins and antibody fragments. Along with being a workhorse for mAb capture, plus protein and nucleic acid contaminant
removal, Protein A chromatography is capable of reducing the amounts of viral contaminants and can be utilized in downstream purification to support viral clearance for GMP manufacturing.

Amsphere™ A3 (A3) is a Protein A chromatography resin used in biopharmaceutical process development and cGMP drug substance manufacturing. Amsphere A3 has very competitive dynamic binding capacity (DBC), alkaline stability, and protein contaminant removal (2, 3). A3 also recently demonstrated effective ability to reduce viral contamination in a study performed by an established contract development and manufacturing organization (CDMO). Several other commercially available Protein A resins were comparatively evaluated in the same study.