As the field moves into large-scale commercial manufacturing, cryopreservation becomes an even more critical component for ensuring maximun efficiency and long shelf-life during end-to-end production. Yet the field still relies heavily on dimethyl sulfoxide (DMSO)- a reagent long associated with cytotoxicity, variable recovery, and poor compatibility with defined, serum-free processes. Particularly, DMSO exhibit acute toxicity in patients and causes adverse cell mutation at low levels including irreversible cell chromosome damage and alterations in the epigenetic landscape. These shortcomings limit scalability, compromise therapeutic quality, and add risk to manufacturing and patient delivery.
Empowered by negligible toxicity, X-Therma offers a next-generation alternative: peptoid-based cryopreservation technology inspired by inspired by anti-freeze protiens in nature. Our lead reagent, XT-Thrive®, is chemically defined, cGMP-grade, and free of DMSO, serum, and protiens. Designed for seamless integration into existing workflows, it removes bottlenecks for large batch production (i.e. long hold times and wash out steps) and enables a highway of premium quality cell products and a better patient experience for many patients in need.
Independent studies confirm that XT-Thrive® consistently outperforms conventional media. Mesenchymal stormal cells (MSCs), T-cells, organoids, and tissues preserved with XT-Thrive® show significantly higher post-thaw viability, proliferation, and functionality. MSCs maintain genomic stability tri-lineage differentiation, while T-cells retain cytotoxicity and phenotype. XT-Thrive® also allows cells to remain stable at room temperature for extended handling- an advantage during filling, transport, and clinical administration.
By removing the constraints of DMSO, X-Therma's peptoid technology sets a new benchmark for safe, reliable, and scalable biopreservation. As CGT manufacturing advances toward industrial scale and serum-free systems, XT-Thrive® provides the field with a long-awaited, non-toxic alternative - empowering broader access to regenerative medicine.
Learning Objectives:
1. Evaluate DMSO cryopreservation limitations across development stages, including cytotoxicity, genomic instability, and scale-up challenges.
2. Understand X-Therma's XT-Thrive® as a safe, DMSO-free alternative offering low toxicity and improved biocompatibility for modern cGMP processes
3. Compare XT-Thrive® benefits to traditional cryomedia, emphasizing better post-thaw outcomes and versatility for various cell types throughout development.