Loren Data's SAM Daily™

FBO DAILY ISSUE OF MARCH 23, 2006 FBO #1578
SOLICITATION NOTICE

R -- Technology Licensing, Cell Development and Manufacturing Technical Support

Notice Date

3/21/2006
 

Notice Type

Solicitation Notice
 

NAICS

541710 — Research and Development in the Physical, Engineering, and Life Sciences
 

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, MD, 20817
 

ZIP Code

20817
 

Solicitation Number

NIAID-VRC-07-41
 

Response Due

5/4/2006
 

Archive Date

5/19/2006
 

Description

The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) has a sole-source requirement for licensing the production technology and producing cell line for the manufacture of non-replication competent clinical-grade adenoviral vectors containing HIV gene inserts. Technology gained under this contract will be used by NIAID to manufacture HIV vaccines to be used in human clinical trials, regulated by the Food and Drug Administration. GenVec (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 a combination firm-fixed and cost reimbursement type contract. Requests for information or questions concerning this requirement must be submitted in writing, and can be directed to LaDonna Stewart at ladonna_steawart@nih.gov by May 4, 2006. See Numbered Note 22.
 

Place of Performance

Address: Bethesda, MD

Zip Code: 20892

Country: USA
 

Record

SN01011266-W 20060323/060321212037 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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