Process Development and Manufacturing: EXPANSION OF DIFFERENT TYPES OF THERAPEUTIC CELLS USING XENOGENEIC FREE AND GAMMA IRRADIATED HUMAN PLATELET LYSATE

ABSTRACT

Background & Aim: Mill Creek’s human platelet lysate (hPL) is produced using expired human platelets obtained from accredited blood banks in the United States. These platelets were originally intended for use in patient transfusion. The safety of platelets used in transfusion is managed by the U.S. Food & Drug Administration (FDA), as well as the American Association of Blood Banks (AABB). These organizations set standards, including testing for transmissible diseases. The United States record for blood safety is well established, with extremely low rates of disease transmission, making the platelet units used for hPL manufacture low risk. However, over the past few decades, the number of emerging infectious diseases that spread to people has increased. Even though transmission of Covid-19 and other potential emergent pathogens via blood transfusion has not been documented, adventitious agents remain a concern. For that reason, pathogen reduction processes are necessary to improve the safety profile of blood-derived products used in the manufacture of cellbased therapies. One of these processes is the pathogen reduction through gamma irradiation. Methods, Results & Conclusion: Previously, we validated a process to produce gamma irradiated human platelet lysate. To be able to release the gamma irradiated product as a pathogen reduced product, we additionally performed a viral clearance study, which determined the efficacy of the process to actually reduce a potential viral contaminant. Here, we present the results obtained from the viral clearance study performed on our gamma irradiated hPL, and from the expansion of different types of therapeutic cells using our gamma irradiated hPLs, which showed unprecedented levels of product quality and efficiency. Our products are a game changer for the growing market of cell base therapies bioprocessing and manufacturing.