mRNA Vaccine Manufacturing

REQUEST FOR INFORMATION W911QY-21-S-mRNA1 mRNA Vaccine 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 Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense Enabling Biotechnology (JPEO CBRND EB) is seeking information on the capabilities and willingness of private entities (academic, non-profit and commercial) for expansion or utilization of established domestic, Good Manufacturing Practices (GMP)-quality mRNA-based vaccine manufacturing. The government is soliciting information on a potential performer's capabilities within two different scenarios: 1) routine medical countermeasure (MCM) vaccine manufacturing, and 2) Rapid response MCM vaccine manufacturing. This RFI is being issued to request information on the following: 1) mRNA manufacturing, including both upstream and downstream capabilities through to drug product (DP); 2) supply chain security, including reliance on OCONUS suppliers, ability to maintain inventory and use of just-in-time supplies; 3) GMP fill and finish of the formulated product, including sample analysis (QA/QC) and activity testing; and 4) your approached to achieve end-to-end integration of the above component systems to produce required capacity in the specified timeline. Background: JPEO CBRND EB is seeking capabilities from multiple sources for development of a domestic mRNA vaccine manufacturing capacity as outlined in the steps above or other means to facilitate mRNA vaccine production. This may include leveraging existing infrastructure, established processes, and/or partnerships to manufacture previously FDA-approved (cleared to market) mRNA-based vaccines as well as the potential to expand current infrastructure, established process, and/or partnerships that can complete regulatory requirements needed for FDA approval and compliance. Additionally, responses outlining how private entities are currently approaching development of de novo in-house capabilities, in addition to the their readiness status, are welcome. This includes providing details on planned or in-progress process development and how the entities are achieving manufacturing and regulatory requirements needed for FDA approval and compliance. The government requires entities to be able to execute in two scenarios: 1) as part of the routine infrastructure of the MCM ecosystem outside of emergency situations, and 2) as a rapid response partner who generates MCM mRNA-vaccines to address urgent demand. Requirements. JPEO CBRND EB would like to understand industries domestic mRNA vaccine manufacturing capacity to source raw materials (including manufacturing consumables such as vials), produce Active Pharmaceutical Ingredient (API) , and fill/finish manufacturing within the two scenarios mentioned above. For the routine MCM development, JPEO CBRND recommends entities have maintained capabilities and capacity for for a minimum of 100,000 doses per year. Doses are defined as 100'g of GMP-grade mRNA formulated within 0.5mL inside 1mL vials or pre-filled syringes. For support of rapid response, entities would be expected to possess or access potential surge capacity of at least 200,000 doses within 2 months. If your capabilities do not currently meet these requirements, please be sure to explain how you intend to meet these surge requirements. Performance Objectives: When responding to this RFI, please provide responses to all or some of development options listed under Objectives and limit responses to 5 pages. Responses should include current industry capabilities from interested entities in the following areas: Existing Capacity and Scale. Do you have existing capability and capacity to meet JPEO CBRN needs as both a routine and rapid response performer? (as specified by above criteria) If yes, what GMP-quality dose quantity could you generate within one year? Within 2 months? In other words, could you support more than requested and if so, how much? Routine MCM Development. (yes/no response) Does your facility accept or have capacity for: Regulatory sponsorship? Regulatory filing? Process development (PD)? Accelerated stability testing? Release criteria testing? Fill and finish capacity? If no to any of the above, would you be willing to update your business practices to include these features. If so, how would you acquire or access this capacity? Rapid Preparedness. Does your facility have a system in place that would support rapid expediting of DoD required vaccines if necessary, even if other customers already have reserved manufacturing slots within your queue? In other words, is there a mechanism to clear available capacity and prioritize DoD needs? What are your planning assumptions for successful rapid turnaround of doses in an emergency scenario? (e.g. multi-dose vials, pre-filled syringes, scale-up, etc) Sourcing raw materials. Does your facility have secure domestic sourcing for pharmaceutical-grade raw starting materials (i.e. nucleotides, capping enzymes, etc)? If not, what would be required for your company to source or secure pharmaceutical-grade starting materials, focusing on options for domestic sources? Does your institution have the capabilities and capacity to secure consumables during the manufacturing process that are domestically-sourced? mRNA Vaccine Formulation, Finished Dosage Form (FDF) Manufacturing & Dose Delivery. Do you have a proprietary or licensed delivery technology for mRNA administration? Has that technology ever been part of an FDA regulatory filing? Are there any partnerships in place that are required for successful mRNA formulation? Please indicate those partners and their locations. What is your delivery route? (e.g. IM, ID, etc) What is your delivery form? (e.g. syringe, patch, electroporation, etc) What are the cold-chain requirements of your product, if any? What would be required of your establishment to accomplish fill-finish/FDF within your facilities to achieve 100,000 doses per year with potential surge capacity for up to 200,000 doses in 2 months? Capacity Expansion (if required). What would be required for you to expand your capacity to the surge capacity limit or beyond? What is the maximal surge capacity of your current facility or facilities? Approximately how many doses could your facility provide in a 2 month period of rapid response? Please include numbers for both DS and filled DP. If your current facility cannot meet a minimum of 200,000 doses within 2 months, what would be required to achieve this minimum? 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 4:00 pm on 26 Apr 2021 . Responses should be sent by e-mail to: Kenneth.v.janosko.civ@mail.mil with Subject Line of Responding Organization and RFI Title.