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17. Detection of Replication Competent Retrovirus and Lentivirus
Retroviral vectors based on murine leukemia viruses (MuLV) have been used in clinical investigations for over a decade. Alternative retroviruses, most notably vectors based on HIV-1 and other lentiviruses, are now entering into clinical trials. Although vectors are designed to be replication defective, recombination events during vector production could lead to the generation of replication competent retroviruses (RCR) or replication competent lentiviruses (RCL). Careful screening of vector prior to human use must insure that patients are not inadvertently exposed to RCR or RCL. We describe methods capable of detecting low levels of virus contamination and discuss the current regulatory guidelines for screening gene therapy products intended for human use.
Affiliation(s): (1) Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN, USA
Series: Methods in Molecular Biology  |  Volume: 506  |  Pub. Date: Jul-01-2008  |  Page Range: 243-263  |  DOI: 10.1007/978-1-59745-409-4_17
Subject:  Cell Biology
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