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Darryl L. Goss joins Bioreliance
Darryl L. Goss has been appointed Vice
President, Toxicology/Laboratory Animal Diagnostic Services (LADS), a new executive position created to lead this newly
formed Business Unit.
Click here to read the
press release.
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The safety testing of cell substrates for the presence of viruses in biotechnology products is an important issue and is required by regulatory agencies world-wide.
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Back to Virology
Viruses that do not cause cytopathic or other noticeable effects in a cell culture system can be detected by an animal system. The International Committee on Harmonisation (ICH) document on 'viral safety of biotechnology products derived from cell lines of human or animal origin' (Q5A), the U.S. Food and Drug Administration and the Center for Biologics Evaluation and Research (FDA/CBER) 1993 Points to Consider (PTC) for cell line characterization and the Notes for Guidance issued by the Committee for Proprietary Medicinal Products (CPMP) require that in vivo tests for the presence of adventitious viruses be performed during various stages of product manufacturing.
BioReliance offers two categories of assays for detecting adventitious viral contaminants:
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