in vivo biosafety testing
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Viral vaccines and cell lines used to produce biologicals must be tested to ensure they are free of adventitious agents (e.g., viruses). While specific viruses can be detected through tests such as PCR, there remains a requirement for an in vivo broad screening assay to identify potential contamination by unspecified agents.
Charles River has laboratories in both the United States and Europe accredited against the relevant regulatory standards (e.g., GLP, GMP, AAALAC) to perform such tests. We partner with you to understand your study and customize our existing standard operating procedures where necessary to fulfill your needs. Safety testing for extraneous toxins is required on each lot of biological product intended for human use, and requirements may exist for the tumorigenic properties of a cell substrate to be determined. Charles River’s In vivo Biosafety groups have the capabilities to conduct these tests as well.
IVB testing services include:
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Mouse/Rat/Hamster Antibody Production (MAP/RAP/HAP)
Simultaneously detects and identifies viral contaminants in biological specimens.
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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.
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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.
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Tumorigenicity Test
Determines whether or not a cell line is tumorigenic.
For details on the location of services performed, please click here. For additional information about our In vivo Biosafety Testing services, contact us at askcharlesriver@crl.com.
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In vivo biosafety, IVB, Mouse Antibody Production, Rat Antibody Production, Hamster Antibody Production, MAP, RAP, HAP, Inapparent Virus Assay, inapparent virus, cell lines, Tumorigenicity, tumorigenic, General Safety Test, Good Laboratory Practice, GLP, non-GLP, Guidance for Industry for Viral Vaccines, Points to Consider, Q5A, CPMP/ICH/295/95, Good Manufacturing Practice, GMP
In vivo Biosafety (IVB) Testing | Charles River
Charles River Biopharmaceutical Services (BPS) provides in vivo biosafety (IVB) testing services according to Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) guidelines.