Biosafety Testing Services for Biologics

Viral vaccines and cell lines used to produce biologics must be tested to ensure they are free of adventitious agents (e.g., viruses). While methods such as PCR can detect specific viruses, a broad range in vivo screening assay can detect potential contamination caused by unspecified agents. Each lot of biologic product intended for human use requires safety testing for extraneous toxins. Additionally, some products require determination of the tumorigenic properties of the cell substrate. Charles River’s In Vivo Biosafety groups routinely perform these tests.

  • 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