X-Therma Inc., a biotechnology company focused on regenerative medicine and organ preservation, announces a notable achievement as the Food and Drug Administration (FDA) accepts its Drug Master File (DMF) for XT-Thrive®. 

This milestone covers the Chemistry, Manufacturing, and Controls (CMC) for XT-Thrive®, a revolutionary cryopreservation solution enabling non-toxic preservation for life-saving regenerative medicines.

Dr. Xiaoxi Wei, co-founder and CEO of X-Therma, describes the acceptance as the culmination of years of development and the establishment of a Good Manufacturing Practices (GMP) facility in Hercules, California. "We are poised to provide worldwide supply of this next-generation product intended for use within the biologics, gene therapy, tissue engineering, and cell therapy sectors," Dr. Wei states.

Submitted in January 2024, the FDA accepted X-Therma's DMF on January 31, 2024. Clients utilizing XT-Thrive® for therapeutic cell preservation can now reference the DMF in their Investigational New Drug (IND) and Biologics License Application (BLA) submissions to the FDA.

XT-Thrive® represents a breakthrough in cryopreservation technology, being DMSO-free, serum-free, protein-free, and chemically defined. It preserves mammalian cells at ultra-low temperatures (-70° C to -196° C) using peptoids, a novel class of cryoprotectant inspired by natural antifreeze proteins. This innovation mitigates the risk of ice damage and eliminates the need for manual wash-out steps, enhancing safety and efficiency in cell manufacturing processes.

Michael Osborne, SVP of Commercialization at X-Therma, emphasizes XT-Thrive®'s superiority, stating, "It is the plug-and-play solution for cell and tissue manufacturing processes to enable greater bioproduction scale-up, reliability, and consistency."