SOURCES SOUGHT
99 -- MCS-JVAP is seeking information from manufacturers with a platform technology capable of generating a vaccine for the prevention of Western, Eastern and Venezuelan equine encephalitis (WEVEE).
- Notice Date
- 12/9/2014
- Notice Type
- Sources Sought
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- ACC-APG - Natick (SPS), ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street, Natick, MA 01760-5011
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-15-C-WEVEE
- Response Due
- 1/15/2015
- Archive Date
- 2/14/2015
- Point of Contact
- Nathan C. Jordan, 508-233-6034
- E-Mail Address
-
ACC-APG - Natick (SPS)
(nathan.c.jordan@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- 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: Medical Countermeasure Systems Joint Vaccine Acquisition Program (MCS-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: MCS-JVAP is seeking information from manufacturers with a platform technology capable of generating a vaccine for the prevention of Western, Eastern and Venezuelan equine encephalitis (WEVEE). The platform technology needs to have been matured in other vaccine programs (e.g., Filo virus, alpha virus, lentivirus, adenovirus). The manufacturer must have the capability to deliver current Good Manufacturing Practices material that will be suitable/acceptable for use in humans by the government to support non-clinical (IND-enabling), and Phase 1 studies under an Investigational New Drug (IND) application. The Government is seeking partners that have their own WEVEE vaccine or a manufacturer with the capability to receive our candidate molecule sequence, clone into their system and leverage their experience with the platform to make material to support non-clinical and clinical supply chain. PURPOSE AND OBJECTIVES: The primary objective of issuing this RFI is to seek information and comments from companies with experience and the capability to leverage their manufacturing platform, standard operating procedures, batch records, and quality systems to manufacture and release drug substance and drug product. Method development for in-process controls, bulk and final drug product will be expected. As such, the Government has interest and is researching information about current industry capabilities via responses to the areas listed below: A. A detailed description of the platform production system oVector construction oCell banking oUpstream and downstream processes for drug substance oDrug product manufacturing, inclusive or stabilization and adjuvant technology oScale-up of the platform and capability for scale-up B. Provide data in support of WEVEE vaccine drug substance or drug product manufactured to date and describe how product performance was assessed. oPilot animal challenge studies oDuration studies oImmunogenicity studies oStability studies C. History of regulatory fillings using the platform for other drug products/IND or BLAs D. Method development plan for in-process testing, drug substance release testing, drug product release testing and stability. (sample plan and testing plan) E. Demonstration of process understanding and line-of-sight from process parameters to quality attributes specifically attributes pertaining to process related impurities. F. cGMP manufacturing; oDescribe your company's experience working the FDA and engaging in meeting and completing submission to the FDA. oDescribe your company's experience manufacturing clinical material and the clinical phase (s) for which the material was manufactured, i.e., Phase 1, Phase 2. oDescribe your company's experience competing for Government contracts negotiated and awarded based on best value tradeoffs. oIndicate 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. G. Describe your companies in house capabilities and those efforts which are subcontracted 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 MCS e-mail address listed below within 5 days after RFI release. SUBMISSION INSTRUCTIONS: All written responses must be received no later than January 15, 2015. Submissions should: (1) use Microsoft Word or Adobe Portable Document Format (PDF); (2) be sent to Nate Jordan at Nathan.c.jordan.civ@mail.mil; (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 Contracting Division, ATTN: Lawrence Mize, 69 Thomas Johnson Drive, Frederick, Maryland 21702. Material that is advertisement only in nature is not desired. Contracting Office Address: US Army Contracting Command - Aberdeen Proving Ground Natick Contracting Division 64 Thomas Johnson Drive, Frederick, Maryland 21702 Point of Contact(s): Nate Jordan, 508-233-6169 Nathan.c.jordan.civ@mail.mil
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/ec74ca241bc639379dc4628ca3d3b0c1)
- Place of Performance
- Address: ACC-APG - Natick (SPS) ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street Natick MA
- Zip Code: 01760-5011
- Zip Code: 01760-5011
- Record
- SN03591533-W 20141211/141209234941-ec74ca241bc639379dc4628ca3d3b0c1 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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