REQUEST FOR INFORMATION -HT9427-26-RFI-705.docx

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Cryopreserved Platelets (CPP) for US FDA Licensure
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HT9427-26-RFI-705
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This is a Request for Information (RFI) issued by the Defense Health Agency seeking industry input on the development and licensure of Dimethyl Sulfoxide (DMSO) Cryopreserved Platelets (CPP) for potential use by the U.S. military. The RFI, numbered HT9427-26-RFI-705, is classified as a pre-solicitation notice and represents an early-stage market research effort rather than a formal procurement action.

The Defense Health Agency's OPMED WPAC Program Management Office is developing a frozen, biologic-platelet product designed to extend shelf life significantly beyond current liquid stored platelet (LSP) standards. While LSP products are currently licensed for storage of only 5-7 days at room temperature (20°C to 24°C) under gentle agitation, DMSO CPP aims to achieve a shelf life of 2 years or potentially longer. The agency is seeking information from commercial partners and interested parties regarding technical feasibility, regulatory pathways to FDA licensure, manufacturing capabilities, and other relevant considerations to support the eventual development and procurement of this medical product for military readiness and warfighter support.

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