SOLICITATION NOTICE
B -- Manufacture and Safety Test Experimental Virus Vaccines
- Notice Date
- 3/29/2010
- Notice Type
- Presolicitation
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- 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-2009029
- 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, Division of Intramural Research has a requirement for a Contractor to manufacture, safety test, and certify experimental non-Influenza and Influenza virus vaccines and other vaccine-related products (i.e., wild-type virus for challenge, cell banks for vaccine production, and vaccine diluent) which have been shown by evaluation in vitro and in vivo to be promising candidates for evaluation of the effectiveness of immunoprophylaxis or pathogenesis studies of human diseases, and will primarily be used in Phase I and II clinical studies. The Contractor must be able to prepare the following virus suspensions as requested by the Government: Paramyxoviruses, Dengue viruses, Flavivirus chimeric viruses, and Influenza A Viruses in vero cells, as well as, embryonated eggs. In addition to the above, the Contractor may also be required to produce and qualify cell lines as directed by the Government representative, for use by the Government and the Contractor in the production of viruses to be administered to humans or for other uses as directed. This may include the production of Master Cell Banks, Working Cell Banks, and End of Production Cell Banks. When necessary, the Contractor may also be requested to assist with basic process development including developing improved manufacturing methods designed to (a) increase vaccine potency (titer); (b) improve vaccine stability; and (c) increase vaccine purity by the reduction of undesirable contaminants such as cellular DNA, serum, and animal derived proteins, and intact cells. Virus vaccines and cell lines produced and qualified for use under this contract will be considered government-owned materials. All production and testing of virus vaccines and production of cell banks shall be prepared using methods and facilities which meet FDA standards for preparation of live virus vaccine candidates and later codified in the current Good Manufacturing and Good Laboratories Practices provisions of the Code of Federal Regulation. It is estimated that a minimum of two (2) and a maximum of six (6) vaccine suspensions will be produced annually, and that at least one cell line will be qualified every other year. The Contractor must be capable of delivering the materials within six months from the date of receipt of seed material. It is anticipated that any award issued from this solicitation will be a one-year, Firm Fixed-Priced, IDIQ-type contract with four (4) one-year options beginning on or about August 1, 2010. The solicitation will be available for download on www.fedbizopps.gov on or about April 12, 2010. No hard copies will be distributed. Requests for information or questions concerning this requirement must be submitted in writing to LaDonna Stewart at lstewart@niaid.nih.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/AMOB/DHHS-NIH-NIAID-AO-2009029/listing.html)
- Place of Performance
- Address: Contractor's facilities, United States
- Record
- SN02105479-W 20100331/100329235024-f8f82e5c4148b3d1d0104974f16d15e6 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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