Author Archives: Atis Chakrabarti

Effective Viral Clearance in mAb Purification Using TOYOPEARL® Resins

Impurities such as viruses are typically present during the manufacturing of biological drugs. The viruses may be present in the unprocessed material from the upstream collected harvest, such as released from cell culture media (endogenous) or accidentally introduced during processing (adventitious). Viral clearance is required by the FDA and international regulatory bodies as specified in the ICH Q5A documents. In this study we evaluated two chromatography steps in the purification of a monoclonal antibody (MAb) for viral clearance. Evaluation was…