in vivo biosafety testing 

It has been well documented that accidental infections or contaminations with indigenous rodent viruses have hampered biomedical research. To be used safely in research and in compliance with government regulations, biologics derived from rodent tissues and cell cultures must be tested to guarantee that they are free of extraneous rodent viruses.

Charles River can help to ensure the validity of your research results and help you meet your research goals. In our AAALAC-accredited In Vivo Biosafety (IVB) Testing Services laboratory in the US, we screen cell lines and other bioproducts according to Good Laboratory Practice (GLP), and also perform non-GLP services as requested. Protocols are designed to meet the requirements of the February 2010 FDA Guidance for Industry for Viral Vaccines, Points to Consider (1993) and Q5A (CPMP/ICH/295/95). 

In vivo biosafety testing following EP monograph 2.6.16 is available to Good Manufacturing Practice (GMP) at two of our locations in Europe. We will partner with you to understand your study and will customize our existing standard operating procedures where necessary to best fulfill your needs.

IVB testing services include:

• Mouse/Rat/Hamster Antibody Production (MAP/RAP/HAP)
  Simultaneously detects and identifies viral contaminants in biological specimens.
  
• Inapparent Virus Assay
  Tests cell lines for extraneous viruses that do not cause any cytopathic or other cytological effects in cell culture. Test protocols are designed to meet various regulatory requirements.
  
• Tumorigenicity Test
  Determines whether or not a cell line is tumorigenic.
  
• General Safety Test
  Determines the safety of a biomedical product in support of investigational and new drug filings; required by federal policy for biologics and vaccine development.

For details on the location of services performed, please click here. For additional information about our In vivo Biosafety Testing servcies, contact us at askcharlesriver@crl.com.