SOURCES SOUGHT
A -- Aluminum Adjuvanted Recombinant Vaccine Drug Product (DP) Formulation Evaluation, DP Process Development and Clinical/Commercial DP Formulation and Filling.
- Notice Date
- 4/25/2018
- Notice Type
- Sources Sought
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- Department of the Army, Army Contracting Command, ACC - APG (W911QY) Natick (SPS), 10 General Green Avenue, Building 1, Natick, Massachusetts, 01760-5011, United States
- ZIP Code
- 01760-5011
- Solicitation Number
- DVC0600-SS-18
- Archive Date
- 5/11/2018
- Point of Contact
- Alesha Subasic, , Jessica L. Ely, Phone: 3016198457
- E-Mail Address
-
alesha.subasic@csra.com, jessica.l.ely.civ@mail.mil
(alesha.subasic@csra.com, jessica.l.ely.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- DynPort Vaccine Company LLC, a General Dynamics Information Technology 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 clinical/commercial cGMP DP manufacturing. These efforts will involve evaluating the current DP formulation, and investigating potential formulation/manufacturing process changes/improvements. Additionally, task may include incorporating the recommended procedures into the clinical/commercial DP formulation and filling manufacturing operations. Finally, responses should consider potential regulatory challenges 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 RFI, however vendors should provide information in the areas that can be supported. Information gathered at this time will help guide DVC in structuring the future potential Request For Proposal (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 past performance for same or similar work performed. Background: The vaccine in the current DP 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 and manufacturing capabilities. • Describe physiochemical analytical capabilities for characterization of an aluminum adjuvanted recombinant vaccine (i.e. purity, protein concentration, particulate identification, aluminum content, etc.) or comparable liquid suspension product. • Provide the qualifications of technical staff with demonstrated experience. • Describe relevant capabilities in Quality Systems, 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 or comparable liquid suspension products. Experience with specific adjuvants and vaccines should be detailed. 3. Describe current and previous experience with compounding and aseptic filling of clinical/commercial liquid suspension product into vials. 4. 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 ultimately develop a commercial process that could be used to manufacture an aluminum adjuvanted recombinant vaccine DP according to cGMP requirements? 2. Describe current and previous experience with manufacturing process development. 3. Describe experience with development of clinical manufacturing processes that were successfully transitioned to commercial manufacturing. 4. Provide a description of analytical capabilities available for DP Critical Quality Attribute (CQA) analysis (i.e. strength, purity, identity, etc.). Task Area C - Clinical/Commercial DP Manufacturing 1. Provide a description of the cGMP manufacturing capabilities of your facility, including number of clinical and commercial products being manufactured, and a description of quality systems. 2. Describe current and previous experience with manufacturing of aluminum adjuvanted and/or liquid suspension products. 3. Provide cGMP manufacturing experience including experience with transitioning products from clinical to commercial stage. 4. Describe production design in regards to flexibility and operating capacity targeting 30,000 to 100,000 unit lot size. 5. Describe how your facility addresses trends and challenges within industry, particularly as related to visual inspection of parenteral products (i.e. elimination of subjectivity in the visual inspection process, addition/changes to the USP guidance on visual inspection, etc.) 6. Provide a description of analytical capabilities available for DP CQA analysis (i.e. strength, purity, identity, etc.). 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 submitted no later than Wednesday, 9 May 2018 4:00 PM, Eastern Standard Time (EST) via email to Alesha.Subasic@CSRA.com. Disclaimer: This notice does not obligate DVC to award a contract or otherwise pay for the information provided in response. Note that DVC will not entertain questions regarding this Market Research; however, general questions can be presented in your response. Confidentiality: No proprietary, classified, confidential or sensitive information should be included in your response.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/a8e1ad6e9e1bb3a39074aaf73781798a)
- Place of Performance
- Address: 110 Thomas Johnson Drive, Frederick, Maryland, 21702, United States
- Zip Code: 21702
- Zip Code: 21702
- Record
- SN04900252-W 20180427/180425230657-a8e1ad6e9e1bb3a39074aaf73781798a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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