X-Therma Receives FDA Approval for XT-Thrive® Drug Master File
Thursday, April 18, 2024
X-Therma Inc., a pioneering biotechnology firm specializing in regenerative medicine and organ preservation, has reached a significant milestone with the Food and Drug Administration (FDA) accepting its Drug Master File (DMF) for XT-Thrive®. This DMF encompasses the Chemistry, Manufacturing, and Controls (CMC) for XT-Thrive®, a groundbreaking innovation facilitating non-toxic cryopreservation crucial for life-saving regenerative therapies.
"This submission represents the culmination of years of dedicated development and the establishment of a state-of-the-art Good Manufacturing Practices (GMP) facility in Hercules, California," stated Dr. Xiaoxi Wei, co-founder and CEO of X-Therma. "We are now well-positioned to supply this next-generation product globally, catering to the needs of biologics, gene therapy, tissue engineering, and cell therapy sectors."
X-Therma presented the DMF to the FDA in January 2024, receiving acceptance on January 31, 2024. Clients utilizing XT-Thrive® for therapeutic cell preservation can now cite the DMF in their Investigational New Drug (IND) and Biologics License Application (BLA) submissions to the FDA, particularly for products falling under the purview of the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
XT-Thrive® represents a revolutionary cryopreservation medium, free of DMSO, serum, protein, and chemically defined, allowing the preservation of mammalian cells at ultra-low temperatures (-70° C to -196° C). It incorporates a novel class of cryoprotectants called peptoids, synthetic molecules inspired by natural antifreeze proteins. These peptoids are highly effective and non-toxic, preventing harmful ice formation and the risk of shock-induced damage. Moreover, XT-Thrive® eliminates the need for a manual wash-out step, enhancing its safety profile compared to other cryopreservation media.
"XT-Thrive® offers unparalleled cell recovery and functionality, presenting numerous advantages over existing products," commented Michael Osborne, SVP of Commercialization at X-Therma. "It serves as a plug-and-play solution for cell and tissue manufacturing processes, facilitating greater scale-up, reliability, and consistency in bioproduction."
Source: prnewswire.com
