SPECIAL NOTICE
A -- Request For Information, Aluminum Adjuvanted Recombinant Vaccine Drug Product (DP) Formulation Evaluation, DP Process Development and Commercial-Scale cGMP Manufacturing.
- Notice Date
- 6/26/2017
- Notice Type
- Special Notice
- NAICS
- 541711
— Research and Development in Biotechnology
- 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
- W911QY-17-S-0014
- Archive Date
- 8/3/2017
- Point of Contact
- Richard Totten, Phone: 3016192446
- E-Mail Address
-
richard.w.totten2.civ@mail.mil
(richard.w.totten2.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- DynPort Vaccine Company LLC, a CSRA Company (DVC), a biopharmaceutical company in Frederick, Maryland, is issuing this Request for Information (RFI) to gain insight into the capabilities of potential industry partners in aluminum adjuvanted recombinant vaccine drug product (DP) formulation evaluation, DP process development and commercial-scale cGMP manufacturing. These efforts will involve evaluating the current DP formulation and investigating potential formulation and manufacturing process changes. In addition, responses should consider potential regulatory issues based on proposed formulation and/or process changes. Note that it is possible that a vendor may not have expertise in all areas of this Request For Information (RFI), however vendors should provide information in the areas that can be supported. Information gathered at this time may help guide DVC in structuring any future potential RFP. This RFI announcement is for information purposes only; it is not to be construed as an obligation on the part of DVC. In order to proactively plan for future requirements, DVC is conducting market research to locate qualified, experienced, and interested large and small businesses to assess qualified, and experienced interested sources. No contract will be awarded from this announcement. No reimbursement will be made for any cost associated with providing information in response to this announcement. Please provide your capabilities statement for the following Task Areas, noting that any or all of the work scope may ultimately move forward. Responses shall include experience for same or similar work performed. Background: The vaccine in the current formulation has been tested in nonclinical safety and efficacy studies. Phase 1 and Phase 2 clinical trials have been completed. Instructions Vendors should respond to one or more of the Task Areas for which they have applicable expertise. For each Task Area to which a vendor responds, please include the following information along with specific responses to the task area questions: • Provide a description of your facility. • Describe physiochemical analytical capabilities for characterization of an aluminum adjuvanted recombinant vaccine (i.e. purity, protein concentration, particulates, aluminum content, etc). • Provide the qualifications of technical staff with demonstrated experience. • Describe relevant capabilities in regulatory affairs and support. Task Area A - Formulation Evaluation and Optimization 1. What scientific approaches would the offeror recommend to evaluate the optimal formulation of an aluminum adjuvanted recombinant vaccine DP formulation? 2. Describe current and previous experience with formulation development of aluminum adjuvanted vaccines. Experience with specific adjuvants and vaccines should be detailed. 3. Describe physiochemical analytical capabilities for characterization of an aluminum adjuvanted recombinant vaccine (i.e. purity, protein concentration, particulates, aluminum content, etc). Task Area B - Process Development 1. What technical approaches and methods would be used to develop a commercial scale process that could be used to manufacture an aluminum adjuvanted recombinant vaccine DP according to cGMPs? 2. Describe current and previous experience with manufacturing process development. 3. Describe experience with development of small scale manufacturing processes that were successfully transitioned to commercial scale manufacturing. Task Area C - Manufacturing at Commercial Scale 1. Provide a description of the manufacturing capabilities of your facility. 2. Describe current and previous experience with manufacturing of aluminum adjuvanted products. 3. Provide cGMP manufacturing experience. Additional Required Information The following information shall be provided: 1. DUNS and CAGE Code Number 2. Tax ID Number 3. Company name and address 4. Principal Point of Contact, phone number and email (both technical and administrative/business) 5. NAICS codes associated with this capability 6. Company size (i.e. small business, 8(a), veteran owned, etc) Contact Information: All responses to this RFI shall be electronically submitted no later than Wednesday, 19 July 2017 12:00 PM, Eastern Standard Time (EST) via email to Deelya.Fulton@csra.com.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/c6d8c93c1c0d6430d103f565eda21bac)
- Record
- SN04557684-W 20170628/170626234834-c6d8c93c1c0d6430d103f565eda21bac (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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