X-Therma Inc., a biotechnology company developing a breakthrough platform for regenerative medicine and organ preservation, has achieved GMP (Good Manufacturing Practice) commercial readiness with its flagship product, XT-Thrive®.
XT-Thrive® enables non-toxic cryopreservation for life-saving regenerative medicines such as vaccines, cell lines for production, cell and gene therapies, and engineered tissues. The DMSO-free, serum-free, protein-free, and chemically defined cryopreservation media is designed to significantly enhance the preservation of biological materials, offering unprecedented efficiency and reliability.
“This announcement marks a critical step forward in ensuring the highest quality and scalability of XT-Thrive® for widespread clinical and commercial applications,” said Mark Kline, co-founder and Chief Technology Officer at X-Therma. “This milestone not only opens new opportunities for advancing cryopreservation solutions that can save countless lives, but also marks the first time peptoids, an emerging class of biomimetic molecules, have been utilized at a market-ready scale.”
In March 2024, X-Therma completed an oversubscribed $22.4 million Series B funding round. The investment enables X-Therma to scale global commercial operations and facilitates the company’s progression into the clinical stage.
“With GMP commercial readiness, XT-Thrive® will meet the stringent quality and regulatory standards required for clinical use, positioning X-Therma as a key player in the biopreservation market,” said Mike Osborne, SVP of Commercial, Regenerative Medicine at X-Therma. “This demonstrates our progression towards being able to meet increasing market demands and support large-scale clinical applications.”
X-Therma has established an independent quality organization and a robust Quality Management System (QMS) that meets U.S. regulatory requirements defined by FDA 21 CFR 210/211, 610, 820, and ICH Quality Guidance. Additionally, with a Drug Master File registered with the FDA, X-Therma operates a GMP manufacturing facility equipped with an automatic aseptic fill/finish line in Hercules, California.
X-Therma will be available to discuss this news at upcoming conferences including:
- May 29-June 1, 2024: ISCT 2024 in Vancouver, Booth #646
- June 1-5, 2024: American Transplant Congress in Philadelphia, Booth #630
- June 3-6, 2024: Biotechnology Innovation Organization (BIO) International Convention in San Diego. X-Therma is scheduling meetings through the BIO One-on-One Partnering™ system.
About X-Therma Inc.
X-Therma Inc. is pioneering breakthrough cold chain technology via a convergent biopreservation platform, to advance regenerative medicine and make available safe and on-demand organs, engineered tissues, cell and gene therapies, vaccines, and beyond to patients in need. Headquartered in Hercules, part of the San Francisco Bay Area and an expanding presence in Austria, X-Therma’s technology is poised to become a paradigm shift that enables worldwide organ sharing and eliminates organ waiting lists across the globe.
About XT-Thrive®
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.
