Cryopreserved Platelets (CPP) for US FDA Licensure
ID: HT9425-25-RFI-PDM-01Type: Sources Sought
Overview

Buyer

DEPT OF DEFENSEDEFENSE HEALTH AGENCY (DHA)ARMY MED RES ACQ ACTIVITYFORT DETRICK, MD, 21702, USA

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) (541715)

Original Source

https://sam.gov/opp/192b183028d34427a87e22a2da7c69e8/view
Timeline
    Description

    The Department of Defense, through the Defense Health Agency (DHA), is seeking input from qualified entities for the development of Dimethyl Sulfoxide (DMSO) Cryopreserved Platelets (CPP) aimed at enhancing the shelf life of platelet products for military use. This initiative is part of the U.S. Combat Casualty Care Research Program and focuses on creating a biologic product that can be stored for up to two years, significantly improving upon the current five-day storage limit for liquid stored platelets. The project is critical for ensuring the readiness and quality of life for active-duty personnel, with a low-rate initial production goal of 1,500 units anticipated over a 20-month performance period. Interested parties are encouraged to submit a white paper detailing their capabilities and relevant experience by January 20, 2025, and can contact Peter Mitchell at peter.d.mitchell8.civ@health.mil for further information.

    Point(s) of Contact
    Peter Mitchell
    peter.d.mitchell8.civ@health.mil
    Files
    Title
    Posted
    CPP-RFI-Doc.docx
    The United States Army Medical Research and Development Command (USAMRDC) issued Request for Information (RFI) HT9425-25-RFI-PDM-01 to seek input on the development of Dimethyl Sulfoxide (DMSO) Cryopreserved Platelets (CPP). This biologic product aims to enhance the shelf life of platelets, extending it to two years compared to the current five-day limit for liquid stored platelets. The RFI outlines the mission to develop medical materials that ensure the readiness of the Warfighter while improving the quality of life for active-duty personnel. The document states that the response is for planning purposes, not a solicitation, and invites interested parties to present their capabilities and approaches to meet FDA standards for manufacturing, storage, and regulatory compliance of CPP. The submission guidelines include providing a white paper and contact information, emphasizing the importance of demonstrating relevant experience and technical capabilities. The anticipated Phase 3 performance period for the CPP initiative is estimated at 20 months, with a low-rate initial production goal of 1,500 units. Submissions are due by January 20, 2025, underscoring the urgency and relevance of collaboration between the government and potential partners in advancing this critical medical product.
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    Cryopreserved Platelets (CPP) for US FDA Licensure
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