SOURCES SOUGHT
99 -- : MCS-JVAP is seeking information from manufacturers with the capability to aseptically fill/finish previously manufactured bulk drug product (DP) into vials.
- Notice Date
- 4/21/2016
- Notice Type
- Sources Sought
- NAICS
- 325199
— All Other Basic Organic Chemical Manufacturing
- Contracting Office
- Department of the Army, Army Contracting Command, ACC - APG (W911QY) Natick (SPS), BLDG 1 KANSAS ST, Natick, Massachusetts, 01760-5011, United States
- ZIP Code
- 01760-5011
- Solicitation Number
- WEVEE2016
- Archive Date
- 6/4/2016
- Point of Contact
- Nathan C Jordan, Phone: 5082336169
- E-Mail Address
-
nathan.c.jordan.civ@mail.mil
(nathan.c.jordan.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Notice Type: Sources Sought Synopsis: 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 Food and Drug Administration (FDA)-licensed vaccine systems to protect the Warfighter from biological warfare agents. The current MCS-JVAP portfolio includes vaccines at various stages of clinical development, in addition to FDA-licensed vaccines. MCS-JVAP supported funding for the development of a virus like particle (VLP) vaccine for Western, Eastern, and Venezuelan equine encephalitis (WEVEE). REQUIREMENT: MCS-JVAP is seeking information from manufacturers with the capability to aseptically fill/finish previously manufactured bulk drug product (DP) into vials. The manufacturer must have the capability to deliver filled/finished material in accordance with current Good Manufacturing Practices (cGMP) that will be suitable/acceptable for use in humans to support non-clinical (IND-enabling), and Phase 1 studies under an Investigational New Drug (IND) application. Specifically, MCS-JVAP is seeking a manufacturer with the capability to receive Government candidate vaccine bulk DP, aseptically fill/finish the material in vials under cGMP conditions, and release it as final DP. The manufacturer, or its subcontractor(s), must also be able to receive technology transfer of all associated tests (e.g. release, stability). PURPOSE AND OBJECTIVES: The primary objective of issuing this RFI is to seek information and comments from companies with the experience and capability to leverage their operational resources and quality systems to fill, finish, and releaseDP. Method development and/or technical transfer and validation for all associated required and informational testing will be expected. As such, MCS-JVAP has interest and is researching information about current industry capabilities via responses to the areas listed below: A. Information required for technology transfer and method development plans for bulk DP release testing upon receipt, in-process testing, basic compounding involving an adjuvant, final DP release and stability testing (sample plan and testing plan). B. Demonstration of fill/finish process understanding and line-of-sight from manufacturing process parameters to final DP quality attributes. C. cGMP manufacturing: o Describe your company's cGMP manufacturing capabilities and quality systems. o Describe your company's experience working with the FDA, including engaging in meetings and completing regulatory submissions. o 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). o Describe your company's experience competing for government contracts that were negotiated and awarded using best value tradeoffs. o 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. D. Describe any of your company's capabilities that are subcontracted. The Government will retain comments and information received in response to this RFI. Questions regarding this RFI should be forwarded to the point of contact address listed below within 5 days after RFI release. Submission Instructions: All written responses must be received no later than May 20, 2016. Submissions should: (1) use Microsoft Word or Adobe Portable Document Format (PDF); (2) be sent to 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 20 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 the Point of Contact at the Contracting Office Address provided below. Point of Contact(s): nathan.c.jordan.civ@mail.mil Contracting Office Address: ACC-APG NCD ATTN: Nathan Jordan 110 Thomas Johnson Drive Frederick, MD 21702 Point of Contact(s): Nathan Jordan, 508-233-6169 Nathan.c.jordan.civ@mail.mil
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/7b4605e2e60c92a14054ca75c822ddb2)
- Record
- SN04092085-W 20160423/160421235218-7b4605e2e60c92a14054ca75c822ddb2 (fbodaily.com)
- Source
-
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