Predicting Viral Clearanceat Your Benchtop

摘要

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 "viral clearance efficacy" of their downstream purification processsteps before clinical trials or commercial approval.