Vector Product Release Testing

Vector Product Release Testing

• Residual Cas9 Detection Assay. Detect and quantify any lingering Cas9 protein in a gene-edited cell product.
• P24 Antigen. Evaluation of lentiviral products using a p24-specific ELISA, utilizing FDA-approved kit technology under cGMP.
• Vector Titer. A variety of infectious and physical titer assays for lentiviral and retroviral particles.
• Vector Insert Stability Assay. Evaluation of vector integrity via restriction enzyme cleavage and Southern blot, performed under cGMP.
• Transfer of E1A and SV40 DNA. Quantitative PCR assessment to ensure HEK293T-associated adenoviral and SV40 sequences are not passed to transduced cells, as required by FDA. Performed under cGMP and available for other targets like VSV-G.