SOLICITATION NOTICE
R -- Technology and Cell Licensing, and Manufacturing Support
- Notice Date
- 12/7/2010
- Notice Type
- Cancellation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy & Infectious Diseases/AMOB, 10401 Fernwood Drive, Suite 2NE70, MSC 4811, Bethesda, Maryland, 20817
- ZIP Code
- 20817
- Solicitation Number
- DHHS-NIH-NIAID(AO)-SS-2011054
- Archive Date
- 3/31/2011
- Point of Contact
- LaDonna R Stewart, Phone: 301-451-8117
- E-Mail Address
-
lstewart@niaid.nih.gov
(lstewart@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) has a requirement to generate and characterize replicated and non-replicated deficient research grade, as well as, pre-GMP adenoviral Vector Seed Stocks (VSS) containing VRC inserts for expressing antigens derived from Human Immunodeficiency (HIV), Simian Immunodeficiency (SIV), Influenza and filoviruses (Ebola and Marburg). Technology gained under this contract will be used by the NIAID to manufacture vaccines to be used in human clinical trials, regulated by the Food and Drug Administration. GenVec, Inc. of Gaithersburg, MD has been identified as the only responsible sole source for this procurement. GenVec is the source of a proprietary packaging cell line (293-ORF6) that has a demonstrated safety profile in the production of adenoviral vectors for use in human clinical trials. In addition, product produced by GenVec has been used in previous clinical trials, and is scheduled to be used in an upcoming Phase II trial. Regulatory requirements indicate that the material for later phase clinical trials must be produced in the same cell line as that used for the initial studies, or the trials will likely need to be repeated at a substantial cost to the government. Switching to a different packaging cell line or manufacturing technology would require a repeat of a substantial number of previously conducted pre-clinical and clinical studies at a significant and unnecessary duplicative cost to the government. It is anticipated that any award issued from this solicitation will be in the form of a combined firm-fixed price and cost reimbursement IDIQ type contract. Requests for information or questions concerning this requirement must be submitted in writing, by email to LaDonna Stewart at lstewart@niaid.nih.gov by January 21, 2011. See Numbered Note 22.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/AMOB/DHHS-NIH-NIAID(AO)-SS-2011054/listing.html)
- Place of Performance
- Address: NIH/NIAID, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02339502-W 20101209/101207233748-8911dcc600ded14afae02d7bf68b3051 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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