In certain situations, the FDA requires testing for replication competent viruses to document the safety of gene therapy products ( PDF). The NGVB offers biologic based assays for virus testing with a focus on testing for retroviral and lentiviral vectors. Assays are performed under Good Manufacturing Practice to meet FDA requirements. Eligible investigators receive testing at a subsidized cost. If you are interested in this service:
If you have any questions feel free to contact the NGVB Manager:
NGVB Manager
317-274-4519
