Clearing the Way for Viral Clearance

This webcast features: David Cetlin, CEO, MockV Solutions and John Li, Staff Scientist, Thermo Fisher Scientific

To determine the viral clearance efficacy of biomanufacturing steps, mammalian viruses are “spiked” into in-process solutions, processed and analysed 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. Discussed here are results from a series experiments in which in-process mAb material was spiked with MVM-MVP and processed through Anion Exchange and Cation Exchange.

Furthermore, in collaboration with Thermo Fisher Scientific, a viral clearance study was performed on Hydrophobic Interaction Chromatography (HIC) resins. In this study, viral clearance was examined on POROS™ HIC resins using several designed polish steps for a clinical stage monoclonal antibody. The predictive power of MVP was evaluated and compared to results from MVM spiking studies.

The results from these studies demonstrate the excellent viral clearance capability of POROS resins and the value of utilizing this non-infectious viral clearance analysis tool for process development and characterization.

Watch the recorded webcast below.