Retroviral and lentiviral vectors are increasingly being used in the engineering of oncologic cell therapies. However, they may pose risk to human health in the event the viral vector becomes replication competent. As a result, these vectors could target non-neoplastic cells during treatment.
Regulatory agencies have provided guidance to developers of cell and gene therapy products for testing the presence of replication-competent viruses such as retroviruses and lentiviruses during follow-up monitoring of patients on these treatments. Approaches to monitoring replication-competent-retrovirus or replication-competent lentivirus have targeted sequences to structural proteins, reverse transcriptase, and envelope glycoproteins.
This poster from Q2 Solutions describes the performance of replication-competent-retrovirus and replication-competent lentivirus assays carrying the gibbon ape leukemia virus envelope and the vesicular stomatitis virus G genes, respectively, using droplet digital PCR (ddPCR) technology to improve accuracy and precision in quantitation.
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