SAM #HT9427-26-RFI-705

Request for Information: Cryopreserved Platelets (CPP) for FDA Licensure – Defense Health Agency

The Defense Health Agency's Army Medical Research Acquisition Activity is seeking industry input on developing Dimethyl Sulfoxide (DMSO) Cryopreserved Platelets (CPP) for US FDA licensure. - Government Buyer: - Army Medical Research Acquisition Activity (AMRAA), Defense Health Agency - Located at Fort Detrick, Maryland - Products/Services Requested: - Biologic product: DMSO Cryopreserved Platelets (CPP) - Designed for extended shelf life (2 years or more) compared to current liquid stored platelets (5-7 days) - No specific part numbers or quantities provided - OEMs and Vendors: - No specific OEMs or vendors named; open to commercial partners with relevant expertise - Unique/Notable Requirements: - Product must be developed for US FDA licensure - Focus on supporting military medical readiness and improving quality of life for active-duty personnel - Seeking collaboration and information from industry on product development and management

Description

 Defense Health Agency seeks to develop and manage medical materiel to protect and sustain the Warfighter on point for the Nation. We develop, directly through collaboration with commercial partners, medical products that enhance readiness and improve the quality of life of active-duty personnel in the operational environment. OPMED’s WPAC PMO has been developing a biologic product: Dimethyl Sulfoxide (DMSO) Cryopreserved Platelets (CPP), a frozen, biologic-platelet product.  DMSO CPP are formulated to provide a platelet-derived product with a longer shelf life (2 years and potentially longer) than liquid stored platelets (LSP), which are currently licensed for storage up to 5-7 days at room temperature (20ºC to 24ºC) under gentle agitation.

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