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As a leader in testing service, Creative Biogene offers a comprehensive replication competent retrovirus testing service for gene-mediated cell therapy and viral vector based gene therapy programs. Our service is available for testing the materials from multiple stages of product manufacture. With years of experience and in-depth investigation, scientists at Creative Biogene develop a rapid, accurate and systemic platform to detect replication-competent retrovirus in accordance with FDA, ICH, and CPMP guidelines in your viral prep.
Retroviral vectors based on murine leukemia viruses (MuLV) were the first viral vectors to enter clinic trials. They are used as a tool to deliver genes. So far, they are widely used in gene therapies and gene-mediated cell therapies. Although retroviral vectors are engineered to be replication defective, it is a possibility to generate replication competent retrovirus during the manufacturing process by recombination. Early studies showed that RCR contaminating retroviral vectors would cause malignancy in both mice and nonhuman primates. Therefore, replication competent retrovirus testing is a necessary procedure of biosafety testing in manufacturing retroviral vectors and related products.
Creative Biogene provides multiple assays to detect RCR, including S+L- assay, PERT assay, the marker rescue assay, XC plaque assay and PCR-based assay. In concordance with the recommendations of FDA, cell culture based method is the best choice for RCR testing. The test articles are co-cultured with a permissive cell line for amplification followed by endpoint detection including S+L- assay, PERT assay, plaque assay and the marker rescue assay. Comparing with the conventional methods, PCR-based assay is faster and simpler. Creative Biogene offers integrated and responsible replication competent retrovirus service to ensure the biosafety of your products.
Sample materials include:
1. Sastry, L., and Cornetta, K. (2009) Detection of replication competent retrovirus and lentivirus. Methods Mol Biol 506, 243-263.
2. Sastry, L., Xu, Y., Duffy, L., Koop, S., Jasti, A., Roehl, H., Jolly, D., and Cornetta, K. (2005) Product-enhanced reverse transcriptase assay for replication-competent retrovirus and lentivirus detection. Human gene therapy 16, 1227-1236.
3. Christopher Baum (ed.), Methods in Molecular Biology, Methods and Protocols, vol. 506 © Humana Press, a part of Springer Science + Business Media, LLC 2009 DOI: 10.1007/978-1-59745-409-4_17.
4. FDA: Briefing Document-Testing for Replication Competent Retrovirus (RCR) / Lentivirus (RCL) in Retroviral and Lentiviral Vector Based Gene Therapy Products-Revisiting Current FDA Recommendations. 2010.
5. Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors. 2006.