DNA and CpG adjuvant Manufacturing

REQUEST FOR INFORMATION DNA and CpG adjuvant Manufacturing Objective: This is a Request for Information (RFI) for planning purposes only. 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. The Joint Science and Technology Office is seeking information on the capabilities and willingness of private entities (academic, non-profit, and commercial) in the two areas listed below. Background: DNA vaccines deliver the target antigen to the host in the form of a DNA sequence. This DNA sequence enters target cells and directs the synthesis of the target antigen. This technology has the potential to overcome safety concerns associated with some live attenuated or recombinant viral vector vaccines. Based on cost effectiveness and ease of manufacture, DNA vaccines enable more rapid responses, a critical element for military operations and addressing newly emerging pathogens in a timely fashion. Plasmid DNA delivered via electroporation is an emerging technology that is now in Phase 3 clinical trials; to date, no DNA vaccine has been approved by FDA. CpG oligodeoxynucleotides (ODNs) are potent activators of the Toll-like receptor 9 (TLR 9) and when used as vaccine adjuvants, improve both humoral and cellular responses. For infectious diseases, this may allow the induction of protective immune responses with fewer and lower doses of antigen. In broad terms, data exists indicating CpG is safe and shows great promise for inclusion in prophylactic vaccines designed to prevent infection. Requirements: The purpose of this RFI is to solicit information on the availability or developmental status of: DNA vaccines as a platform technology for select pathogens. To pursue these DNA vaccines, DTRA requires a proven DNA vaccine manufacturer capable of producing vaccines at a commercial scale under Good Manufacturing Process (GMP) level of quality for use in a Phase I clinical trial. CpG ODNs as an adjuvant for select vaccines at a commercial scale under Good Manufacturing Process (GMP) level of quality for use in a Phase I clinical trial. Performance Objectives For the purpose of information on the vendor's capability to provide DNA Vaccine manufacturing under GMP conditions, assuming the vendor would be supplied with Master Cell Banks, the following information is being sought: Description of upstream manufacturing process Description of downstream manufacturing process Manufacturing experience with scaling, the speed of the scaling and at what scales of production Typical yields at different scales Efficacy testing and comparative analysis between different GMP lots GMP manufacturing experience Experience with stability studies FDA familiarity with manufacturing process The vendor's track record of brining manufactured product into the clinic For the purpose of information on the vendor's capability to provide CpG ODN manufacturing under GMP conditions, the following information is being sought: Description of manufacturing/synthesis process Experience with scaling and description of synthesis scales Typical yields at different scales GMP manufacturing experience Experience with stability studies FDA familiarity with manufacturing/synthesis process The vendor's track record of brining manufactured product into the clinic RFI Format: The Government requests that potential performers provide a 3 page response containing at a minimum the above information on the ability to either: Manufacture a GMP DNA vaccine and experience with regulatory approval process; And/or Manufacture/Synthesize CpG ODNs and experience with regulatory approval process. The Government requests information from vendors with successful experience in the following: obtaining FDA concurrence with the manufacturing process to include the analytical, immunological, and efficacy testing required to demonstrate acceptable DS and DP. coordinating, conducting, and managing communications on manufacturing process (written, oral, email) with the FDA. preparation of manufacturing documents for submission to FDA. The Government desires a manufacturer with the following capabilities/experience: A) 2 or more DNA vaccines that are in Phase I or beyond Ability to deliver product within 12 months of a contract/task award And/Or B) CpG ODNs included in a Phase I trial or beyond Ability to deliver product within 12 months of a contract/task award Assumptions: The Government would provide master cell banks (as applicable). The materials manufactured would be used to support a Phase I clinical trial. All necessary manufacturing information (to include but not limited to: analytical assay SOPs, process SOP's, reference materials, batch records, lot numbers, stability information, toxicology study reports, and dose modeling) would need to be provided to the Government or Vaccine sponsor. Administration: 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. All written responses must be received by COB on 15 November 2021. Responses should be sent by e-mail to: contact@example.gov, with Responding Organization's name and RFI Title in the Subject Line. The Government will hold a virtual industry day in conjunction with this RFI on 9 November 2021, 1:30 pm - 3:00 pm EST. The Government is also considering virtual one-on-one question and answer sessions after the closing date and after responses have been thoroughly reviewed. An amendment will be issued with specific instructions for participating in the Industry Day. Material that is advertisement only in nature is not desired. If a solicitation is subsequently released based on the responses to this RFI the first choice for an acquisition vehicle, if appropriate, will be the Medical CBRN Defense Consortium (MCDC) Other Transaction Agreement (OTA). Respondents not already members of the consortium are encouraged to join at www.medcbrn.org. Respondents may also inquire about the MCDC at contact@example.gov.