Archiving Services

As gene therapy products are developed and brought to clinical trials, the US FDA requires collection and storage of materials that can be accessed, as needed, at later time points (PDF). Some material may need to be stored for years (up to 15) after the clinical trial. To assist with these requirements, the NGVB provides archiving services at no charge to the investigator.

Services are provided to investigators from academic or other non-profit institutions (see Eligibility) who must archive samples to meet FDA guidelines or are specified in IRB approved clinical trials. Samples accepted include (but are not limited to):

FDA Gene Therapy Guidance
Click for PDF

Clinical Trial Samples. Clinical trial samples collected during post-trial monitoring can be sent and stored in the Indiana University Biorepository at no cost to the investigator. See Clinical Trial Testing/Archive - Request Form to request clinical trial sample archive services.

Pharmacology and Toxicology Archive. If you have performed Pharm/Tox studies submitted to the FDA and have material that must be maintained under GLP conditions, the NGVB will store the samples at no cost to academic investigators. All we ask is that your study be summarized in the NGVB Pharm/Tox database. See Pharm/Tox Archive Request Form to request pharm/tox archive services.

Clinical Grade Vector, Cell Lines, and Clinical Study Samples. The NGVB will also store reserve or back-up clinical grade vector, master cell banks, and clinical study samples. This will insure that should a catastrophic event occur at the investigators current storage site, additional material would be available at the NGVB. Contact the NGVB Cooridinating Center for more information.