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 performed with four model viruses commonly used for the testing of MAb products.
Studies were performed as spike/chase experiments, where a known quantity of virus is added to unprocessed material, and remaining virus is quantitated following processing. A schematic for chromatography step testing is shown in the Methods – General section.
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