Cryopreserved Platelets (CPP) for US FDA Licensure

The Defense Health Agency (DHA) is seeking information from potential vendors to develop and manage medical materiel, specifically Cryopreserved Platelets (CPP), for US FDA licensure. The CPP product is a frozen, biologic-platelet product with a longer shelf life than liquid stored platelets. The agency is looking for vendors who can demonstrate their ability to perform the scope of work identified in the RFI, including technical expertise, knowledge, and management capability. The submission should include a white paper, a rough order of magnitude (ROM) cost estimate, and contact information. • The CPP product is formulated to provide a platelet-derived product with a longer shelf life (2 years and potentially longer) than liquid stored platelets. • In vitro studies demonstrate that compared to LSP, CPP is potentially more hemostatically active. • OPMED’s past and current industry and academic partners have manufactured clinical-grade lots of CPP and performed Phase 1 and Phase 2 clinical studies under a US Investigational New Drug (IND) application. • The EUA period of performance is estimated to take no longer than sixty (60) months.