X-Therma Inc., a biotechnology company developing a breakthrough platform for regenerative medicine and organ preservation, announces that the Food and Drug Administration (FDA) accepted a Drug Master File (DMF) covering its product, XT-Thrive®. This DMF covers the Chemistry, Manufacturing and Controls (CMC) for this key chemistry innovation, which enables non-toxic cryopreservation for life-saving regenerative medicines.
“This submission was the culmination of several years of development activities and the establishment of a Good Manufacturing Practices (GMP) manufacturing facility in Hercules, California,” says Xiaoxi Wei, Ph.D., co-founder and Chief Executive Officer of X-Therma. “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.”
X-Therma submitted the DMF to the FDA in January 2024, and the FDA accepted it on January 31, 2024. X-Therma clients who use the product to preserve therapeutic cells will be able to reference the DMF in their Investigational New Drug (IND) and Biologics License Application (BLA) submissions to the FDA for products in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
XT-Thrive® is a DMSO-free, serum-free, protein-free, and chemically defined cryopreservation media enabling the preservation of mammalian cells at ultra-low temperatures (-70° C to -196° C). It incorporates a fundamentally new class of cryoprotectant, named peptoids, fully synthetic defined molecules are inspired by natural antifreeze proteins (hyper-effective and non-toxic) to prevent aberrant ice formation and risk of shock-induced ice damage. This product can be used for the cryopreservation of cells used for manufacture of biological products including monoclonal antibodies, recombinant proteins, fusion proteins, and vaccines. XT-Thrive® does not require a manual wash-out step, thus elevating its safety profile in comparison to other cryopreservation media.
“XT-Thrive® is tailored to provide high cell recovery and functionality that poses many advantages over other products on the market,” says Michael Osborne, MBA, SVP of Commercialization at X-Therma. “It is the plug-and-play solution for cell and tissue manufacturing processes to enable greater bioproduction scale-up, reliability, and consistency.”
