Author Archives: David Cetlin

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

To determine the viral clearance efficacy of biomanufacturing steps, mammalian viruses are “spiked” into in-process solutions, processed and analyzed for reduction.  Due to the infectious nature of these live viruses, “spiking studies” are typically conducted in specialized BSL-2 facilities. The costs and logistics associated limit viral clearance analysis during process development and characterization.  To overcome this challenge, a non-infectious minute virus of mice–“Mock Virus Particle” (MVM-MVP) was generated by MockV Solutions, Inc. for use as a BSL-1, economical spiking surrogate.…

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…