A--cGMP contract manufacturer with Biosafety Level 3 containment manufacturing capability.

This is a Request for Information (RFI) for planning purposes only, as defined in FAR 15.201e. This is not a solicitation for proposals. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. 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. BACKGROUND: Chemical Biological Medical Systems Joint Vaccine Acquisition Program (CBMS-JVAP) is the DoD organization responsible for developing, producing and stockpiling FDA-licensed vaccine systems to protect the Warfighter from biological agents. The current CBMS-JVAP portfolio includes vaccines at varying stages of clinical development in addition to Food and Drug Administration (FDA) licensed vaccines. REQUIREMENT: CBMS-JVAP is seeking access to a manufacturer with the capability to deliver a current Good Manufacturing Practices product that will be suitable/acceptable for use in humans by the government to support non-clinical and Phase 1 studies under an Investigational New Drug (IND) application. Specifically, the Government is seeking a manufacturer with the capability to conduct manufacturing efforts in a Biosafety Level 3 containment facility. The Government plans to initiate manufacturing efforts in early 2011. PURPOSE AND OBJECTIVES: The primary objective of issuing this RFI is to seek information and comments from companies with experience and the capability to develop, manufacture and produce a vaccine under cGMP manufacturing in a BSL-3 containment facility. As such, the Government is researching information and interest about current industry capabilities via responses to the areas listed below: A. Describe your companys in-house capabilities/facilities in the following areas: process development; BSL-3 cGMP manufacturing; assay development; and Quality Assurance. B. Describe your companys experience working the FDA and engaging in meeting and completing submission to the FDA. C. Describe your companys experience manufacturing clinical material and the clinical phase (s) for which the material was manufactured, i.e., Phase 1, Phase 2. D. Describe your companys experience competing for Government contracts negotiated and awarded based on best value tradeoffs. E. Indicate company business size (based on the NAICS size standard), business status (i.e., large business, small business, disadvantaged, service-disabled veteran-owned small business, etc.), and date of incorporation. The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary. Do not use Government Security classification markings. Questions regarding this RFI should be forwarded to the CBMS e-mail address listed below within 5 days after RFI release. SUBMISSION INSTRUCTIONS: All written responses must be received no later than December 10, 2010. Submissions should: (1) use Microsoft Word or Adobe Portable Document Format (PDF); (2) be sent to contact@example.gov; (3) be minimum 11 font on 8.5 X 11 paper; (4) be complete, sufficiently detailed, and organized in a manner that tracks to the information requested in this RFI; (5) include a single company point of contact with name, title, address, telephone and fax numbers, and e-mail address(es); and (6) not exceed 10 single sided pages in total (not including cover page and cover letter). Other media types (i.e. CD, printed technical information) that meet the submission criteria above will be accepted and should be sent to US Army Research, Development, and Engineering Command, ATTN: Lawrence Mize, 64 Thomas Johnson Drive, Frederick, Maryland 21702. Material that is advertisement only in nature is not desired. Contracting Office Address: US Army Research, Development, and Engineering Command 64 Thomas Johnson Drive, Frederick, Maryland 21702 Point of Contact(s): contact@example.gov