MicroSafe Services - Xenotropic/Ecotropic Murine Leukemia Virus Testing | Data Sheet - SDS1703ENEU | |
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The risk of viral contamination is a feature common to all biotechnology products derived from cell lines. Murine cells used to produce biopharmaceutical products are known to harbor infectious retroviruses due to the breeding program (loss of a suppressor function on endogenous virus sequences) when used to produce the standard laboratory mouse. Retroviruses in these murine cells pose a particular problem in assessing the safety of cell substrates, as they may be transmitted in the germ line, since the viral genome persists within the cell. These endogenous retroviruses may be expressed without deleterious effects on the cells, and could be infectious to human cells.
The absence of murine retroviruses should be demonstrated using infectivity assays. Detection of murine retroviruses using the cytopathic effect (CPE) is a safety risk due to the low levels of the retrovirus that might be present and undetectable by cytopathology methods.
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