SOLICITATION NOTICE
B -- Manufacture and Safety Testing of Experimental Virus Vaccine Products
- Notice Date
- 3/30/2007
- Notice Type
- Solicitation Notice
- 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, MD, 20817, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- NIAID-DIR-07-49
- Description
- The National Institute of Allergy and Infectious Diseases, Division of Intramural Research has a requirement for a contractor to provide the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to prepare suspensions of viruses which have been shown by evaluation in vitro and in vivo to be promising candidates for use in immunoprophylaxis of human diseases. These virus suspensions, which are intended for evaluation in volunteers, shall be prepared using current Good Manufacturing Practices (cGMPs) and in facilities which meet FDA standards for preparation of live virus vaccines to be tested in Phase 1 and 2 clinical studies as described in the most current Code of Federal Regulations. In addition, suspensions of wild type viruses may also be prepared, which are needed for evaluation of effectiveness of immunoprophylaxis. These suspensions of vaccine or wild type virus shall be safety tested for use in human subject studies as required by the FDA. It is estimated that a minimum of four (4), maximum of ten (10) virus suspensions will be made annually, and that one cell line will be qualified every other year. Potential offerors must be able to prepare the following virus suspensions and associated services as requested by the project Officer: Paramyxoviruses, Dengue viruses, Flavivirus chimeric viruses, and Influenza Viruses. Offerors must be capable of delivering the materials within six months from the date of receipt of seed viruses and avoid using animal-derived materials in vaccine manufacture whenever possible. Offerors must produce and qualify cell lines as directed by the NIAID Project Officer for use by NIAID staff and by the contractors in the production of viruses to be administered to humans or for other uses directed by the Project Officer. Virus vaccines and cell lines produced and qualified for use under this contract will be considered government-owned materials. It is anticipated that any award issued from this solicitation will be a one-year combination Firm Fixed-Price, IDIQ-type contract with four (4) one-year options beginning on or about June 1, 2007. The solicitation will be available for download on www.fedbizopps.gov on or about April 9, 2007. 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.
- Place of Performance
- Address: Contractor Facilities
- Zip Code: 00000
- Country: UNITED STATES
- Zip Code: 00000
- Record
- SN01262891-W 20070401/070330220430 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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