SOURCES SOUGHT
B -- Manufacture and Safety Test Experimental Vaccines
- Notice Date
- 9/30/2009
- Notice Type
- Sources Sought
- 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-SS-OA2009029
- Archive Date
- 10/1/2010
- 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 is currently seeking small business sources capable of providing personnel, material, equipment, and facility resources - not otherwise provided by the Government - 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 use in immunoprophylaxis of human diseases. These vaccine suspensions will primarily be used in Phase I and II clinical studies. and therefore must 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. The Contractor must have the knowledge, skill, and ability to prepare virus suspensions of the following type: Paramyxoviruses; Dengue viruses; Flavivirus chimeric viruses; and Influenza A Viruses in Vero cells as well as embryonated eggs - and deliver final suspension lots within six months of receiving seed material. In addition to preparation of vaccine suspensions, the Contractor may also be required to produce and qualify cell lines as directed by the Government, 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. It is estimated that up to four vaccine suspensions will be produced annually. The contractor may also be required to qualify at least one cell line during the overall contract performance period. When necessary, the Contractor will also be required 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. This announcement is not a request for proposals, but a survey of the market for potential small business sources capable of providing the requested products and/or services. Interested small business parties must provide a capability statement of no more than 5 pages which demonstrates the technical and space capacities for performing the required services. Prospective parties should also include information regarding the availability of personnel experienced and qualified in the preparation and production of vaccine suspensions including wild-type viruses, as well as, the availability of facilities which meet FDA and CFR standards for producing vaccines to be used by humans. This notice is for small businesses respondents only. As such, capability statements should also include documentation indicating that offerors business size meets current standards as determined by the Small Business Administration's Table of Size Standards located at:(http://www.sba.gov/services/contractingopportunities/sizestandardstopics/tableofsize/index.html) for NIAICS 325414. This standard is currently 500 employees, but is subject to change. Prospective offerors may also note whether they meet other socio-economic business categories such as 8a, Hub-Zoned, or Service Disabled Veteran All capability statements should be submitted to LaDonna Stewart at lstewart@niaid.nih.gov no later than 10:00 am EST, on October 15, 2009.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/AMOB/DHHS-NIH-NIAID-SS-OA2009029/listing.html)
- Place of Performance
- Address: Contractor's Facility, United States
- Record
- SN01976726-W 20091002/091001002153-31184748bd320a4e72d4c4d45000a21c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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