SAN FRANCISCO, April 17, 2024 /PRNewswire/ -- 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).