Detection of Replication Competent Lentivirus Using a qPCR Assay for VSV-G.

ABSTRACT: Lentiviral vectors are a common tool used to introduce new and corrected genes into cell therapy products for treatment of human diseases. Although lentiviral vectors are ideal for delivery and stable integration of genes of interest into the host cell genome, they potentially pose risks to human health, such as integration-mediated transformation and generation of a replication competent lentivirus (RCL) capable of infecting non-target cells. In consideration of the latter risk, all cell-based products modified by lentiviral vectors and intended for patient use must be tested for RCL prior to treatment of the patient. Current Food and Drug Administration (FDA) guidelines recommend use of cell-based assays to this end, which can take up to 6 weeks for results. However, qPCR-based assays ar

SUBMITTER: Skrdlant LM 

PROVIDER: S-EPMC5633339 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature