Viral safety is required for biologics manufactured to treat human diseases. It is mandated to demonstrate safety by going through stringent evaluation of virus removal or inactivation capability of the downstream purification process. Minute Virus of Mice (MVM) is a parvovirus commonly used in viral clearance validation studies as a model virus. Due to its small size and chemical stability, it is a very challenging virus to remove and/or inactivate.  In this study, we investigate the use of MVM-mock virus partical (MVP) and bacteriophage PhiX174 as cost-effective surrogates to MVM for viral clearance studies. We show comparability to MVM data in various modes of chromatography. The capabilities and current limitations of the virus surrogates were evaluated. Case studies where risk mitigation pre-screening using these virus surrogates will be presented to evaluate process change effects on viral clearance prior to the costly viral clearance studies at contract research organizations.

Evaluation of cost-effective viral surrogates for viral clearance studies for bioprocessing

2019 Spring National Meeting

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