A Quality By Design Approach To Viral Clearance: Predicting LRV Through The Use Of A Non-Infectious MVM Surrogate

To determine viral clearance efficacy of biomanufacturing steps, viruses are “spiked” into in-process solutions, processed and analyzed for reduction.  Due to the infectivity of these viruses, studies are conducted in BSL-2 facilities.  Costs and logistics limit analysis during process development.  Discussed here are results from several studies that utilized a non-infectious Mock Virus Particle (MVP) as an MVM surrogate.  The results demonstrated the value to be gained from such a QbD approach during process optimization.