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Biotechnology Services
Gene Therapy Products |
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Replication competent retrovirus (RCR) detection
Although retrovirus vectors have a safe history of use in gene therapy protocols, knowledge of the long-term risks of retrovirus exposure is limited. It is essential that retrovirus-packaging cell lines and virus vectors for clinical use do not contain RCR. Both should be tested accordingly. Features of our service include:
- Expert regulatory and technical advice from highly qualified staff with relevant experience
- Amplification of retrovirus on Mus dunni cells (five passages) using PG4 S+L- assay (for the detection of murine xenotropic and amphotropic retroviruses) as end-point. The assay is validated to detect one RCR in 300 ml using the recommended ATCC reference standard.
- Amplification of retrovirus on FG10 cells (five passages) using FG10 S+L- focus assay as endpoint for the detection of murine ecotropic/amphotropic retroviruses (used in preference to PG4 cells in rare circumstances)
- Patient monitoring by immunoassay
- Custom-designed assays available on request. Let us know your requirements and we will satisfy them.
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