Cryopreserved Platelet (CPP) Process Development and Scale-Up

The contract seeks to develop and optimize the manufacturing process for dimethyl sulfoxide cryopreserved platelets with a focus on formulating stable cryoprotectant solutions, establishing efficient freezing and thawing protocols, and scaling the process under Good Manufacturing Practice standards to enable long-term storage. The work will involve refining each stage of production to ensure platelet viability and functionality after cryopreservation, with an emphasis on reproducibility, consistency, and compliance with regulatory requirements for clinical use. The goal is to transition from lab-scale techniques to a robust, GMP-compliant manufacturing system capable of consistent, high-yield output. Performance will be centered in Frederick, Maryland, with a strict deadline for submission on May 4, 2026, and the contract is classified as a subcontract under NAICS code 325412, which corresponds to pharmaceutical and biological product manufacturing. The effort is being led by the Army Medical Resources Acquisition Activity under the Department of Defense, indicating the project’s relevance to military medical readiness and the need for shelf-stable platelet products for field use. The work requires expertise in cell cryobiology, process engineering, and quality systems to meet the unique demands of preserving platelets for extended periods without compromising their hemostatic capabilities.