Manufacture and Safety Test Experimental Virus Vaccines

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The National Institute of Allergy and Infectious Diseases (NIAID), Division of Intramural Research (DIR) is 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 (ie., wild-type virus 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 Phase 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 Regulations. 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 ebryonated eggs - and deliver final suspension lots within six months of receiving seed material. It is estimated that up to four vaccine suspensions will be produced annually. 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. 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. It is anticipated that an award will be made in August 2016 and include one base year and four option years. Any potential contractors should respond with a capability statement submitted electronically to the Contract Specialist, Patrick Wilson, at wilsonpm@mail.nih.gov by March, 17 2016 at 9:00 am EST. Capability statements must be limited to 10 pages or less and must reference relevant work of similar scope that has been performed by the contractor and the dollar value of that work. Capability statements must also detail current in-house capability and capacity to perform the work and information regarding management staff expertise, including their availability, experience, and formal and other training. Offerors that do not include this information will not be deemed capable for the purposes of this survey. Potential offerors must indicate business size and type (e.g., 8(a), HUBZone, etc) in their capability statement. All small businesses must demonstrate that they are capable of performing 51% or more of the required services. Respondents should also include company DUNS number, organization name, and address along with the capability statement. This is a market survey, not a request for proposals. All questions must be directed, in writing, to Patrick Wilson at wilsonpm@mail.nih.gov. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.