Predicting Viral Clearance Through CHO-RVLP And MVM-Mock Viral Particles: Characterization, Analysis And Utility In Downstream Process Development Activities

By David Cetlin, M.S.. Senior Director, R&D, Cygnus Technologies, LLC

Viral contamination poses a significant risk in biopharmaceutical manufacturing, necessitating costly viral clearance validation studies mandated by regulatory bodies. These studies, conducted in BSL-2 facilities, demonstrate the effectiveness of the manufacturing process in removing or inactivating viruses. However, their expense limits the viral clearance knowledge gained during process development. A cost-effective, accurate, and quantifiable non-infectious viral surrogate is therefore highly desirable.

This work evaluates non-infectious CHO-Retrovirus Like Particles (RVLP) and Minute Virus of Mice—Mock Virus Particles (MVM-MVP) as surrogates for Xenotropic Murine Leukemia Virus (XMuLV) and Minute Virus of Mice (MVM), respectively. The study details the creation of surrogate stock solutions, their physicochemical characterization and quantification methods, and presents clearance data obtained using various chromatography and filtration methods. These results demonstrate the advantages of using RVLP and MVM-MVP for efficient and effective viral clearance studies during process development and characterization.