Research Models and Services
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Research Models and Services
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In Vivo Biosafety Testing Preclinical safety testing is a requirement for biopharmaceutical production, as it impacts initial clinical trial parameters. Testing bioproducts in vivo with animal models allows researchers to gather valuable safety and toxicity data. This approach allows a bioproduct’s individual components to be examined and their potential toxicities on target tissues to be determined. Additionally, animal biodistribution data aids researchers in making safety decisions, such as estimating initial human dose and the dose escalation scheme, as well as identifying problems prior to clinical trials. Charles River Laboratories offers In Vivo Biosafety Testing Services to screen cell lines and other bioproducts. Our laboratory is AAALAC-accredited, and we perform preclinical studies in compliance with FDA Good Laboratory Practice (GLP). To learn more about our in vivo testing capabilities, please contact Technical Services at 1-800-338-9680. Mouse/Rat/Hamster Antibody Production The Mouse/Rat/Hamster Antibody Production (MAP/RAP/HAP) assays are immunologically-based protocols designed to simultaneously detect and identify murine viral contaminants in biological specimens. The assays are sensitive, specific, and comprehensive. They can be performed under both GLP and non-GLP conditions. To submit test articles for MAP/RAP/HAP testing, please provide 5 x 106 cells/mL for completion of the test panel. Cells should be diluted 1:1 in supernatant or 1:4 in ascites. No additional media is required. Inapparent Virus Assay Cell lines derived from rodent tissues and cell cultures require GLP in vivo biosafety testing prior to cell banking and cell characterization. These protocols support the “Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals.” We offer the Inapparent Virus Assay to test for extraneous viruses that do not cause any cytopathic or other cytological effects in cell culture. General Safety Test The General Safety Test is available for determining the safety and efficacy of a biomedical product in support of investigational and new drug filings. This in vivo test is required by federal policy for vaccine development. All preclinical research studies are completed according to GLP policies. Tumorigenicity Studies Human cell lines used for live virus vaccine production or gene therapy must be tested to determine if they cause tumors (e.g., are tumorigenic) when injected into a research model. These GLP studies are completed utilizing protocols developed based on the guidelines in the “Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals.” Annually, Charles River completes over 400 antibody production studies and inapparent virus tests, many of which are certified release/efficacy tests. Our professional staff uses standard operating procedures or customizes a study protocol to client specifications. The turnaround time for In Vivo Biosafety Testing Services is 6-8 weeks for most tests; the turnaround on the General Safety Test is approximately 2 weeks. Upon study completion, an original hard copy final report with results plus required Study Director signatures and QA statement is shipped directly to the client. We will also send a faxed copy for client convenience as a secondary method of result transmission.
For a complete listing of our Research Animal Diagnostic Services, please view the 2008 Research Models & Services Catalog. | 
For a Test Article Submission Form, please contact our Technical Services Department at 1-800-338-9680 or email comments@crl.com. 2008 RMS US Catalog: In VivoBiosafety Testing Information Packet In VivoBiosafety Testing Datasheet Reference: "Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use" (FDA Center for Biologics Evaluation and Research, February 1997) Reference: "Virus PCR Assay Panels - An Alternative to the Mouse Antibody Production Test" (Lab Animal, February 2004) What's New |
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