Acquisition of Clinical Grade Adeno-Associated Virus vector for Gene Therapy

This is a Notice of Intent, not a request for proposal.

The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with the Indiana University Vector Production Facility (IUVPF)to procure acquire frozen aliquots of a solution of concentrated clinical grade lentivector encoding DNA sequence for the p47phox protein that conforms to GMP quality control standards as applied to the production, quality and safety testing, packaging and release criteria. The lentivector will be used by Laboratory of Clinical Immunology and Microbiology (LCIM) to conduct a clinical trial of gene therapy using a vector encoding the gene for the p47phox protein to treat and correct the blood stem cells of patients with the autosomal recessive p47phox deficient genetic type of Chronic Granulomatous Disease CGD.

The statutory authority for this sole source requirement is 41 U.S.C. 1901(e)(2) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements.

THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide comparable products or services may submit a capability statement of no more than five (5) pages by email to LaDonna Stewart at lstewart@niaid.nih.gov. The subject line must reference NOI-NIAID-1918532 and capability statements must be received by 10:00 am Eastern Standard time on Tuesday August 21, 2018. All responses received by the closing date and time of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.

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