Virus Clearance Validation Services - Confidence^®

“Retrovirus clearance studies should be performed prior to Phase 1 trials”  

“Clearance studies for other viruses and/or other contaminants should be carried out prior to production for Phase 2/3 trials and may need to be repeated if the final manufacturing process has changed. “

_{Source: Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use, 1997  (FDA-1994-D-0318)}

“Careful design of viral clearance studies using different methods (orthogonal) of virus inactivation or removal in the same production process in order to achieve maximum viral clearance”  

“Viral clearance evaluation studies are performed to demonstrate the clearance of a virus known to be present in the MCB and/or to provide some level of assurance that adventitious viruses which could not be detected, or might gain access to the production process, would be cleared.”

_{Source: Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, 1997}

“prior to Phase I studies, ...,, the process should be evaluated for the inactivation/removal of an enveloped virus and a small non-enveloped virus, unless otherwise justified. Two orthogonal steps should be assessed, if possible.”  

“Whenever significant changes... in the manufacturing process are made... additional virus studies may be needed.”

_{Source: Guideline On Virus Safety Evaluation Of Biotechnological Investigational Medicinal Products, 2008 EMEA/CHMP/BWP/398498/2005 (2008)}