SOLICITATION NOTICE
A -- Manufacture, Test and Facilitate the Phase 1 Clinical Trial of a Dengue Vaccine using FDA cGMP guidelines.
- Notice Date
- 10/5/2011
- Notice Type
- Justification and Approval (J&A)
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, NMLC, 693 Neiman Street, FT Detrick, Maryland, 21702-9203, United States
- ZIP Code
- 21702-9203
- Solicitation Number
- N3239811RCYG014
- Archive Date
- 10/27/2011
- Point of Contact
- Thomas L. Hood, Phone: 3016198894
- E-Mail Address
-
thomas.hood@med.navy.mil
(thomas.hood@med.navy.mil)
- Small Business Set-Aside
- N/A
- Award Number
- N62645-11-C-4047
- Award Date
- 9/27/2011
- Description
- JUSTIFICATION AND APPROVAL FOR USE OF OTHER THAN FULL AND OPEN COMPETITION 1. Contracting Activity. Contracting Activity: Naval Medical Logistics Command (NMLC), Acquisition Management Directorate, Code 02, 693 Neiman Street, Fort Detrick, MD 21702, is acquiring on behalf of the requesting agency: Naval Medical Research Center (NMRC), 503 Robert Grant Avenue, Silver Spring, MD 20901. 2. Description of the Action Being Approved. Approval is requested to award a single contract to GenVec Inc., 65 W. Watkins Mill Road, Gaithersburg, MD 20878 to 3. Description of Supplies/Services The NMRC has a critical need to facilitate the manufacturing, testing and phase 1 clinical trial of a dengue vaccine using FDA cGMP guidelines. This requirement entails the production of two adenovirus vector-based vaccines under cGMP guidelines, from virus seed stocks, using the 293-ORF6 cell line. The first vaccine will consist of a 24 Liter production of dengue-1/dengue-3 bivalent vaccine based on a modified Ad5 vector, to cGMP standards suitable for clinical use. The second vaccine will consist of a 24 Liter production of dengue-2/dengue-4 bivalent vaccine based on a modified Ad5 vector, to cGMP standards suitable for clinical use. Both vaccines must be tested for sterility (including the absence of mycoplasma), vector concentration, infectivity, transgene expression, purity and identity. The two vaccines must then be combined and vialed. Oversight of all activities must be completed to ensure quality suitable for clinical use. The period of performance for this contract is anticipated to be a single period of 180 days (no options). The type of funds being utilized in the base period are FY2010 Research, Development, Test and Evaluation (RDT&E). 4. Statutory Authority Permitting Other Than Full and Open Competition. 10 U.S.C. 2304(c)(1), One source or limited sources. 5. Rationale Justifying Use of Cited Statutory Authority. GenVec is the only source that can meet the requirements of the government because manufacture of both dengue vaccines requires the use of information proprietary to GenVec. Both vaccines require use of GenVec's patented Ad5 vector and GenVec's patented 293-ORF6 cell line. 6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable. The proposed contract was synopsized on the FedBizOpps website on 29 August 2011. No other known sources have expressed an interest in allele resolution genetic typing. 7. Determination of Fair and Reasonable Cost. The Contracting Officer will perform a price analysis in order to determine that the anticipated cost to the Government of the services covered by this J&A will be fair and reasonable. The Independent Government Cost Estimate (IGCE) and past purchase history will form the basis of the price analysis. 8. Actions to Remove Barriers to Future Competition. For the reasons set forth in Paragraph 5, NMLC has no plans at this time to compete future contracts for the type of services covered by this document. If another potential source emerges, NMLC will assess whether competition for future requirements is feasible.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N3239811RCYG014/listing.html)
- Record
- SN02603247-W 20111007/111005235055-293a1e20d23218e821beeb9a39eaa4c9 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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