Millipore Technical Publications |
 | DS- SDS1705ENEU | |
MicroSafe Biosafety Solutions Laboratory, Europe - Replication Competent Retrovirus Testing | ||
| Lit No: | SDS1705ENEU | |
| Year: | 2006 | |
| Scientific progress over the past decade has led to the development of gene therapy products that involve the genetic modification of a person’s cells to treat or cure disease. Since gene therapy products contain genetic and other biological materials, many of the quality, efficacy and safety considerations that apply to recombinant DNA (rDNA) products and other biologicals manufactured by modern biotechnological methods will apply at certain stages in their manufacture.1 A significant safety concern is the potential presence of Replication Competent Retrovirus (RCR) in retroviral or adenoviral vector-based gene therapy products. 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 are tested to confirm absence of RCR. Click the PDF above for the full document. | |
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