Gene Therapy Testing Laboratory

Welcome to the IU Gene Therapy Testing Laboratory

The IU Gene Therapy Testing Laboratory (GTTL) pioneered the gold standard cell culture method for detecting replication-competent viruses (RCVs) that can arise during manufacturing through recombination or mutation. Our critical safety testing mitigates potential risks to patients, including adverse immune responses and tumorigenesis in patients.

We specialize in Biologics Safety Testing and Gene Therapy Product Release Testing, providing the rigorous quality assurance needed to advance novel gene therapy products. Our core services include:

• Replication-competent retrovirus and lentivirus testing (biologic and PCR-based assays)
• Vector insert stability analysis (Southern blot)
• E1A and SV40 testing (PCR-based assays)
• Endotoxin testing (LAL gel clot assay)
• Vector copy number analysis (ddPCR-based assays)

The IU GTTL also houses the National Gene Vector Biorepository (NGVB), an NIH-funded resource offering free testing services to eligible investigators.