The National Institute of Allergy and Infectious Diseases, Division of Intramural Research is currently seeking 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. The Contractor must be able to prepare the following virus suspensions and associated services as requested by the Government: Paramyxoviruses, Dengue viruses, Flavivirus chimeric viruses, and Influenza A Viruses in embryonated eggs. All production and testing of virus vaccines 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. The contractor may also be required to produce and qualify cell lines as directed by the Project Officer 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 two (2) to four vaccine suspensions will be produced annually in Vero cells or embryonated eggs; and that at least one cell line will be qualified every other year; and the Contractor must be capable of delivering the materials within six months from the date of receipt of seed material. 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 sources. Interested parties must provide a capability statement which demonstrates the Contractor's technical capacity for performing the required services, including 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 production of virus vaccines to be used in humans. In addition to the above referenced specifics, capability statements should include the offerors business size as determined by the current Small Business Administration's Table of Size Standards (http://www.sba.gov/services/contractingopportunities/sizestandardstopics/tableofsize/index.html) for the NAICS relevant to this requirement (325414). All capability statements should be submitted to LaDonna Stewart at
[email protected] no later than 2:00 pm EST, January 22, 2009.