Author Archives: David Cetlin

Predicting Viral Clearance at Your Benchtop

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 process steps before clinical trials or commercial approval. This technology review describes the MockV MVM kit for viral clearance…

Monoclonal Antibody Aggregate Polish and Viral Clearance Using Hydrophobic-Interaction Chromatography

Hydrophobic Interaction chromatography (HIC) is a powerful polishing tool for the downstream purification and manufacture of biotherapeutics. HIC offers orthogonal selectivity for the clearance of difficult process and product-related impurities such as aggregates, host cell proteins and endogenous and adventitious viruses.  In this study, a family of POROS HIC resins with novel ethyl and benzyl chemistries was used to successfully polish two clinical stage monoclonal antibodies harboring very high levels of product aggregation (>10%). In addition to aggregate removal, viral…

Modeling Virus Clearance: Use of a Noninfectious Surrogate of Mouse Minute Virus As a Tool for Evaluating an Anion-Exchange Chromatography Method

Viral safety is a critical focus during biopharmaceutical manufacturing (1–5). Although well-characterized mammalian cells such as the Chinese hamster ovary (CHO) line have been used for decades, both endogenous expression of retroviral-like particles and exogenous contamination events from viruses warrant continued vigilance (6, 7). International regulatory agencies require biomanufacturers to validate the “viral clearance” efficacy of their downstream manufacturing process steps before resulting products can be awarded clinical trial or commercial approval (8–10). Currently, viral clearance testing is based on…