Charles River has laboratories in both the United States and Europe accredited against the relevant regulatory standards to perform in vivo biosafety testing. This testing is necessary for viral vaccines and cell lines used to produce biologicals to ensure they are free of adventitious viral agents.
Safety testing for extraneous toxins is required for lot release of biological products intended for human use and requirements also exist for the tumorigenic properties of some cell substrates to be determined. Charles River has the capabilities to conduct these tests. Studies are customizable to fulfill specific client needs.
In Vivo Biosafety Testing Services
Mouse/Rat/Hamster Antibody Production (MAP/RAP/HAP) Test - simultaneously detects and identifies viral contaminants in biological specimens
Inapparent Virus Assay - screens cell lines for extraneous viruses that do not cause any cytopathic or other cytological effects in cell culture; protocols designed to meet various regulatory requirements
Safety Test/Abnormal Toxicity - determines the safety of a biomedical product in support of investigational and new drug filings; required by federal policy for biologics and vaccine development
Tumorigenicity Test - determines the tumorigenic potential of a cell line