Viral contamination is an inherent risk during the manufacture of therapeutic products such as antibodies, vaccines, viral vectors, and plasma derivatives. Whether introduced endogenously from raw materials or exogenously through manufacturing operations, unmitigated viral contaminations can lead to serious health implications and facility shutdowns. Thus, international regulatory agencies require sponsoring companies to validate the āviral clearance efficacyā of their downstream purification process steps before clinical trials or commercial approval.
This technology review describes the MockV MVM kit for viral clearance prediction. Fill out the form below to read the complete article now.