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The National Gene Vector Biorepository (NGVB)

We are an NHLBI/NIH funded resource for investigators conducting clinical gene therapy research.

Our databases and educational resources are open to everyone. Other services may be limited to academic institutions, non-profit organizations, and companies that qualify for NIH small-business grants.

Archiving

Archiving

The NGVB can provide GLP archiving of samples generated for Pharm/Tox studies. Storage of GMP material and clinical samples is also available. The services are provided free for eligible institutions.
Testing

Testing

The FDA requires testing of vector products, gene modified cells, as well as post-trial monitoring of patients treated with gene therapy. The NGVB provides an array of tests to help investigators meet these unique FDA requirements.

Pharmtox Database

Pharm/Tox Database

The NGVB provides detailed summaries of over 50 gene therapy Pharmacology and Toxicology studies. We can facilitate letters of cross-reference so investigators can avoid repeating studies already on file with the FDA.


Reagent Repository

Reagent Repository

The NGVB has a repository of over 80 reagents, including AAV and lentiviral vector plasmids, certified cell lines, and retroviral packaging cell lines.

Seqmap 3

Seqmap 3

SeqMap 3 is a publically available bioinformatics tool suitable for identifying vector insertion sites from Next-Gen Sequencing of LAM-PCR and nrLAM-PCR products.

Educational Resources

Educational Resources

This website provides links to funding agencies, NIH resources, gene therapy societies, and important FDA documents.



What's New at the NGVB

The NGVB continues to provide services to a large number of investigators moving the gene therapy forward.

The NGVB with the assistance of a cancer immunotherapy investigators have published a study of replication competent virus testing in over 400 T cell products intended for infusion into cancer patients. There was no evidence of virus suggesting the testing performed on the vector should be sufficient to exclude contamination with recombinant viruses. This work calls into question the current FDA requirement for testing T cell products and suggests this costly requirement should be discontinued.

The NGVB has recently released SeqMap3, an updated version of our insertion site analysis tool.

Our Pharm-Tox Database has hit 50! There are now a total of 50 studies within the database.

The NGVB Policy and Procedure Manual has been updated to specify that Small Businesses (i.e. those eligible to apply for Small Business Grants from the NIH) are also eligible to receive NGVB support.

NGVB is dedicated to facilitating clinical gene therapy, please contact us for any questions or suggestions on additional services that we could provide.