Special Notice Request for Interest in Lyophilized Pathogen Reduced Cryoprecipitate Manufacturing Advancement

Purpose: The purpose of this Special Notice Request for Information is to seek interested and capable parties in advancing the Department of Defense (DoD) industrial base in Lyophilized Pathogen Reduced Cryoprecipitate Blood Products. Summary: The DoD recognizes that traditional acquisition strategies can often impede efforts to keep pace with the speed of technology's evolution. The Industrial Base Analysis and Sustainment (IBAS) office intends to advance manufacturing readiness in the area of Freeze Dried Plasma (FDP), specifically focusing on Lyophilized Pathogen Reduced Cryoprecipitate Blood Products using an Other Transaction (OT) agreement in accordance with 10 U.S. Code - 2371b. An OT process framework will provide responsiveness, flexibility, and government/industry collaboration to maintain pace with that evolution. The end state of this RFI is to determine the manufacturing readiness level (MRL) and technology readiness level (TRL) of our valued industry partners to advance this technology to FDA approval. Request: Interested parties are requested to provide White Paper responses outlining possible technical solutions, capabilities, and critical cost/schedule drivers related to the following areas: 1. Technical experience with designing and producing pathogen reduced plasma and cryoprecipitate blood products for FDA approval, to include all available FDA registration and listing information. 2. Plan to conduct a formal meeting with the FDA for guidance on regulatory strategy, including timelines for preliminary Investigational New Drug (IND) meetings. 3. Plan and timeline to file a Biologics License Application (BLA) with human clinical data for safety and efficacy for lyophilized plasma products; reference any expected feedback from the FDA regarding proposed safety and efficacy studies. 4. Plan and timeline to file an Investigational New Drug (IND) application, Premarket Approval (PMA), or Premarket Surveillance (PMS) supplement with the FDA and provide validation data, and in vitro testing data to assure the quality of the product. 5. Outline basic elements of the regulatory strategy to achieve FDA approval of a Lyophilized Pathogen Reduced Cryoprecipitate product, to include a chemistry, manufacturing, and controls (CMC) plan. 6. Include process for production of a lyophilized fibrinogen complex and completed proof of principle studies demonstrating bioequivalence to the FDA approved frozen lyophilized fibrinogen complex. 7. Plan to achieve compliance on changes to any already cleared pathogen reduced plasma and cryo plasma/cryoprecipitate products. 8. Applicability of product for dual use with DoD and Civilian marketplace. 9. Shared investment strategy for Phase2/Phase3 clinical trials beyond the 24 months of prototype full scale manufacturing. 10. Provide qualification reports for the manufacturing facility selected. Please document the manufacturer's experience producing 21 CFR Part 210, 211, and 600 compliant lyophilized or cryoprecipitate blood products. If a manufacturing facility or partner has not yet been secured, please describe your quality system for performing audits, site inspections, and qualifications to ensure that a competent and experienced manufacturer is selected. The cover page of the response shall include the company name, Commercial and Government Entity (CAGE) Code (if available), business type (Large of Small), based upon the North American Industry Classification System (NAICS) code 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology), address, point of contact including phone number and email address. Responses shall be submitted in Microsoft Word format and limited to no more than 12 pages using 12 point Arial or Times New Roman font, highlighting the areas listed above. Lack of experience in any category should not preclude interested vendors from submitting RFI responses. Responses: The response shall be due no later than 1:00 PM Eastern Daylight Time (EDT) on September 23, 2021. The responses shall be emailed to mark.a.muniz6.civ@mail.mil. The Government intends to utilize responses to this special notice request to formulate our final contracting strategy for the advancement of Lyophilized Pathogen Reduced Cryoprecipitate Blood Products. While it is our full intent to utilize a competitive process for this effort, the Government reserves the right to limit further competition based on the input received from this notice, as is practicable to achieve flexibility and efficiency. Therefore, all interested parties should respond to this notice in order to maintain consideration for this prospect. Disclaimer: This notice does not constitute an invitation for bids or a request for proposal and is not a commitment by the U.S. Government to procure subject products or services nor will the Government reimburse any parties for costs associated with this request. The Government will use the information received to forge its acquisition strategy. Additionally, all submissions become government property and will not be returned. No basis for a claim against the Government shall arise as a result from a response to this special notice request. /Posted under W900KK-FY22-Lyo_Cryo_Special_Notice_RFI/