Vector Product Release Testing

• P24 Antigen. IU GTTL will evaluate lentiviral products for p24 Antigen using a p24 specific ELISA . The assay utilizes FDA approved kit technology and is performed under cGMP.
• Vector Titer. The IU GTTL offers a variety of infectious titer and physical titer assays designed to detect lentiviral and retroviral particles in suspension.
• Vector Insert Stability Assay. IU GTTL will evaluate retroviral vector and lentiviral vector for vector integrity. The analysis uses restriction enzyme cleavage followed by hybridization with specific DNA probes designed for the vector being evaluated (Southern blot). The assay is performed under cGMP.
• Transfer of E1A and SV40 DNA into target cells. The HEK293T cell used for many lentiviral vector preparations contain sequences from the adenovirus (E1a) and SV40 virus. The FDA requires documentation that DNA from these viruses are not passed along to vector transduced cells. IU GTTL has developed a method to assess this by evaluating vector transduced cells for E1a and SV40 DNA using quantitative PCR. The assay is performed under cGMP. The assay is also available for other targets, including VSV-G sequences.