Abstract
The Bio-virus safety committee, one of the committees of the Parental Drug Association Japan (PDA Japan), has discussed various concerns on biopharmaceuticals from scientific, technical and regulatory perspective. One of the most significant concerns is the risk of viral contamination into the products. This risk should be addressed, as required per the international regulations, by minimizing to use raw materials sourced from animal origin and by performing viral clearance studies in order to evaluate capability of purification processing to reduce and/or inactivate known and/or adventitious viruses. The Bio-virus safety Committee has reported the conclusions of discussion how to prepare and qualify cell bank system as one of raw materials and how much Log Reduction Value (LRV) should be targeted in virus clearance studies in the annual conference of the PDA Japan in 20051). The Bio-virus safety committee has discussed the practical experimental procedures for viral clearance studies since 2006 and reported the conclusions in the annual conference of the PDA Japan in 2007. In this report, standardized and practical experimental procedures for viral clearance studies are shown, considering not only requirements for submission to regulatory agencies but also experimental technique. In addition, trouble shooting based upon experiences of the members, information regarding Contract Research Organizations (CROs), reference of international guidelines, and worksheets of viral clearance study are provided.
