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FBO DAILY ISSUE OF JUNE 28, 2012 FBO #3869
SOLICITATION NOTICE

A -- Adenovirus Vectors Manufacturing

Notice Date
6/26/2012
 
Notice Type
Presolicitation
 
NAICS
325414 — Biological Product (except Diagnostic) Manufacturing
 
Contracting Office
N62645 Naval Medical Logistics Command 693 Neiman Street Ft. Detrick, MD
 
ZIP Code
00000
 
Solicitation Number
N62645ADMANUF
 
Response Due
7/12/2012
 
Archive Date
7/27/2012
 
Point of Contact
Thomas Hood 301-619-9236
 
Small Business Set-Aside
N/A
 
Description
The Naval Medical Logistics Command (NAVMEDLOGCOM) intends to award a sole source contract under the authority of FAR 6.302-1 to GenVec, Inc (Gaithersburg, MD), for the performance of research and development (R&D), in support of the Naval Medical Research Center (NMRC). This requirement is to for the manufacturing of Vector Seed Stock (VSS), Clinical Seed Stock (CSS) and Master Viral Bank (MVB)/Clinical Trial Material (CTM) of three adenovirus vectors (GCXX) encoding three Plasmodium falciparum sporozoite/liver stage antigens, including the conduct of a stability program for the MVB/CTM. The period of performance is anticipated to be for a 36-month base period with two 12 month option periods for maintaining the stability program (one 12-month period/one added stability test for each option). The estimated value of the contract is $3.6 million. GenVec has developed a proprietary supporting cell line, called 293-ORF6. This helper cell line has been genetically modified to produce the two adenoviral protein products of the deleted E1 and E4 genes. The presence of these essential proteins in the 293-ORF6 cells allows the complete assemblage of progeny adenovirus and thus normal replication competence. The 293-ORF6 cell line was developed by GenVec specifically to support the growth and manufacturing of its doubly deleted vectors, and was used to produce NMRC s HuAd5 vaccine constructs that have been tested in four clinical trials. GenVec maintains a Biologics Master File at the FDA describing the growth and safety characteristics of the cell line that collaborators such as NMRC can cross-reference in their IND applications to the FDA. No other company or entity has access or the right to use the 293-ORF6 cell line to manufacture the GC vectors for NMRC without a license from GenVec. It is thus an absolute requirement that manufacturing the VSS, CSS and MVB/CTM be conducted under the auspices of GenVec. This Notice of Intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data, including cost, sufficient to determine capability. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. All capability statements received by 9:00 AM Eastern Time, 12 July 2012 will be considered by the Government. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to NMLC-Research@med.navy.mil.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N62645ADMANUF/listing.html)
 
Record
SN02786274-W 20120628/120626234942-90fbba72b8dd9265b342f0c9024c58b3 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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