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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.
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Cell substrates and raw materials used in the manufacturing of biological products can potentially harbor adventitious agents, including viruses, mycoplasmas and other contaminants.

Adventitious Viruses

Back to In Vitro Testing

Contamination of some biological products, such as vaccines, hormones, and clotting factors, has resulted in the transmission of infectious disease to humans. The purpose of the in vitro assays for adventitious viruses is to detect viruses in master and working cell banks or in unpurified bulk harvest. The in vitro assays use three or more detector or indicator cell lines, of which one or more cell lines are selected on the basis of the history and species of the test article cell line. The following cell lines can be used: human diploid lung (MRC-5) cells, African green monkey kidney (Vero) cells, human epithelial carcinoma (HeLa) cells, bovine kidney (MDBK) cells, and Swiss mouse embryo fibroblast (MEF) cells. The use of multiple assay endpoints, such as observation for cytopathic effect (CPE), hemadsorption (HAD), and hemagglutination (HA), facilitates the detection of a broad range of viruses. These assays are screening assays and are not optimized for specific viruses. The exception is the in vitro assay for the presence of murine minute virus (MMV), which is optimized to detect MMV contamination. MMV (or MVM) is a murine parvovirus that is capable of infecting mouse, hamster (particularly Chinese hamster ovary), and human cells. The biopharmaceutical industry and regulatory agencies have expressed concern about potential MMV contamination in cell substrates. In addition to the in vitro MMV assay, BioReliance also offers a quantitative polymerase chain reaction (QPCR) assay designed for cell or bulk harvest test articles.

 
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