Cryopreserved Platelets (CPP) for US FDA Licensure

The United States Army Medical Materiel Development Activity (USAMMDA), under the Defense Health Agency, is seeking industry partners to develop and manage Dimethyl Sulfoxide (DMSO) Cryopreserved Platelets (CPP), a frozen biologic-platelet product designed to provide a longer shelf life compared to traditional liquid stored platelets. The primary objective is to develop an FDA-licensable product with a potential 2-year or longer storage capability, supporting the U.S. Combat Casualty Care Research Program. Interested parties must submit a comprehensive white paper not exceeding 10 pages, including a rough order of magnitude (ROM) cost estimate and contact information, to peter.d.mitchell8.civ@health.mil by 3:00 PM Eastern on January 20, 2025. The technical requirements include developing FDA-compliant manufacturing processes, establishing storage and shipment procedures, conducting clinical trials, and managing Investigational New Drug (IND) application #14047. Evaluation will likely focus on technical capabilities, manufacturing feasibility, and potential for meeting military medical product standards.

The pre-solicitation notice indicates no specific set-aside designations for this contract opportunity. The project contemplates a Low-Rate Initial Production of 1,500 units over three years, with 500 units produced annually. The Phase 3 period of performance is estimated at 20 months and includes plans to enroll up to 5 additional clinical sites and potentially treat 200 additional patients. While specific award values are not explicitly stated, the contract will be administered through the Defense Health Agency, with USAMMDA's Warfighter Protection and Acute Care Project Management Office serving as the program office. The contract falls under NAICS category 541715 for Research and Development in Physical, Engineering, and Life Sciences, suggesting a focus on advanced medical research and product development for military medical applications.