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 Practice (GMP) 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 upstream and downstream process development for the manufacturing of Virus Like Particles (VLPs), RNA viral vaccine vectors or DNA Vaccines. Manufacturing within a Biosafety Level 3 (BSL-3) containment facility is a requirement. The Government plans to initiate process development and manufacturing efforts in mid-to-late FY13. 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 a robust GMP manufacturing process for production of VLP, RNA viral vaccine vectors such as VRP or DNA vaccines and to provide the Government with a technical data package for technology transfer. As such, the Government has interest and is researching information about current industry capabilities via responses to the areas listed below: A. Describe your company's in-house capabilities/facilities in the following areas: - Process development, including aspects of Quality by Design, process control strategies, key process parameters, process validation capabilities and/or other components that have been implemented; - VLP, RNA viral vaccine vectors such as VRP and DNA Vaccine production; - To develop a robust manufacturing process, including identification of critical quality attributes, development of Upstream and Downstream Standard Operating Procedures, Batch Records, drug formulation and process scale up. The capability to develop appropriate fill, finish and release testing for the characterization of MCB, WCB, DS and DP; To design and implement Stability Optimization/Testing procedures; - A description and the capabilities of the Quality Assurance program to ensure facility cGMP manufacturing compliance. B. Describe your company's experience working with the FDA, including any experience with expediting products through the FDA or through manufacturing practices. C. Describe your company's experience manufacturing clinical material and the clinical phase(s) for which the material was manufactured, i.e., Phase 1, Phase 2. D. Describe your company's BSL-3 capabilities and resources to support select agent work. E. Describe your company's experience competing for Government contracts negotiated and awarded based on best value tradeoffs and experience with implementing technology transfer; F. 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 September 7, 2012. 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 Contracting Command, Aberdeen Proving Ground, Natick Division 1564 Freedman Drive, Fort Detrick, MD 21702 ATTN: Lawrence Mize. Material that is advertisement only in nature is not desired. Point of Contact(s):
contact@example.gov Contracting Office Address: US Army Contracting Command, Aberdeen Proving Ground, Natick Division 1564 Freedman Drive, Fort Detrick, MD 21702 Place of Performance: US Army Contracting Command, Aberdeen Proving Ground, Natick Division 1564 Freedman Drive, Fort Detrick, MD 21702 Point of Contact(s): Nathan Jordan,
+1 (555) 000-0000
