Cryopreserved Platelets (CPP) for US FDA Licensure

The Defense Health Agency, through its Warfighter Protection and Acute Care Project Management Office, is seeking industry input to advance the development and FDA licensure of Dimethyl Sulfoxide (DMSO) Cryopreserved Platelets (CPP), a biologic product designed to extend platelet storage life from the current 5 to 7 days to a minimum of two years at ultra-low temperatures of ≤-65°C. This initiative aims to enhance military medical readiness by providing a stable, transfusable platelet product suitable for deployment in austere and combat environments where refrigerated storage is impractical. The effort builds on prior clinical work under IND #14047 and requires commercial partners with the capability to advance CPP through regulatory pathways, including submission of a Biologics License Application, adherence to current Good Manufacturing Practices, and demonstration of in vivo efficacy and safety comparable to liquid stored platelets. Respondents must hold or commit to sponsoring the IND and possess direct experience with FDA regulatory processes. The solicitation, identified as RFI HT9427-26-RFI-705, is a pre-solicitation information-gathering effort under FAR 52.215-3 and does not constitute a contract award or binding solicitation. Responses are due by May 4, 2026, and must be submitted electronically via email in a single document not exceeding 10 pages, limited to 3 MB, and formatted in Times New Roman 12-point font with one-inch margins. Submissions must include a white paper detailing technical expertise and FDA experience, a rough order of magnitude cost estimate, and a contact information table containing required entity identifiers such as CAGE code, SAM UEI, and small business status. All data must be marked as Controlled Unclassified Information (CUI), and responders must maintain active SAM registration, a DCAA-approved accounting system, and the ability to manage ultra-low temperature logistics under military deployment constraints. While specific packaging, labeling, or MIL-STD requirements are not detailed, the product must be stored and transported at ≤-65°C, and no delivery or payment terms are defined at this stage. The point of contact for submissions is Peter Mitchell of the Defense Health Agency Contracting Agency at Fort Detrick, Maryland, where final evaluations and future contract actions are expected to be managed.