Leveraging bioanalytical characterization of fractionated monoclonal antibody pools to identify aggregation‐prone and less filterable proteoforms during virus filtration
Solomon Isu,
Lilia Vinskus,
Derek Silva
et al.
Abstract:Monoclonal antibodies (mAbs) are an essential class of biotherapeutics. A platform process is used for mAb development to ensure clinically safe and stable molecules. Regulatory authorities ensure that mAb production processes include sufficient viral clearance steps to achieve less than one virus particle per million doses of product. Virus filtration is used for size‐based removal of enveloped and nonenveloped viruses during downstream processing of mAbs. Process development in mAb purification relies on emp… Show more
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