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Validation of a quantitative PCR (qPCR) assay for the detection and quantification of replication competent lentivirus for patient monitoring in lentiviral vector-based cell therapy studies

October 20, 2024
AAPS PharmSci360 2024 -- Lentiviral vectors are a common delivery system for various cell therapies, such as CAR/TCR-T cell therapies. There is a potential risk for replication competent lentivirus (RCL) in patients receiving lentiviral vector-based cell therapies. There is a critical need for regular RCL monitoring in patients. PCR-based assays for RCL detection are recommended by the FDA. Our objective was to validate a qPCR assay based on quantification of vesicular stomatitis virus glycoprotein (VSV-G) envelope protein gene sequence for RCL.