The world has been waiting for the next scientific breakthrough in cryopreservation.
Dimethyl sulfoxide (DMSO), a by-product of the wood industry, has been in use since 1953. It is one of the most studied pharmaceutical agents in the United States. Worldwide, more than 10,000 articles have been written on its medical and clinical implications. In practice, it penetrates the skin deeply and quickly without damaging it. In the United States, DMSO has Food and Drug Administration (FDA) approval only for use as a preservative of organs for transplant (although unused) and for interstitial cystitis, a bladder disease. Doctors have prescribed it for ailments which include treating pain, inflammation, arthritis, scleroderma and interstitial cystitis.
In the field of cryopreservation, DMSO is often used in 5 to 10% formulation along with HSA/FBS as a cryoprotectant agent for cells and tissues. In cell preservation specifically, cell functionality is greatly impaired by DMSO, as a multitude of studies show a low rate of cell survival after being thawed from the cryopreservation process. This challenge is often incredibly costly for scientific development and manufacturing organizations — not only financially, but its significant role in disrupting the ability to complete the work. Due to these concerns over toxicity, side effects of its strong odor (comparable to the smell/taste of garlic) which can include vomiting, diarrhea and injection site pain, it has fallen out of favor with the medical mainstream. Moreover, as a toxic and viscous liquid, DMSO requires premium plastics to be used for safe handling, adding to the cost borne by laboratories.
In the six decades that have passed since 1953, there has not been a non-toxic alternative to DMSO.
Times are changing. In 2023 at X-Therma, cryopreservation methods are being revolutionized. The introduction of XT-Thrive as a next-generation cryoprotectant agent will help carve a new path to the acceleration of more optimal treatments for patients in the overall field of biologics to include vaccines and cell and gene therapies. By removing toxicity from the equation and providing more time to scientists, researchers and cell and gene therapy manufacturing professionals are now able to slow the rate of degradation in cells, tissues and vaccines that are preserved. As a result, significant improvements in cell viability and cell functionality can be achieved. When cells are put in a healthy environment with which to grow from, cell growth rates substantially increase and therapeutic productions thrive. Ultimately this gives the biotech/biopharma community to include innovator organizations and worldwide CDMO’s alike (contract development and manufacturing organizations) the ability to bring more safe and effective treatments to patients much faster.
X-Therma has essentially developed the first non-toxic cryoprotectant solution that is safer and more effective for drug development projects worldwide. XT-Thrive is completely serum-free, protein-free, DMSO-free, fully chemically defined with a drug master file (DMF), and is already transforming the way our world is able to preserve cells, tissues and vaccines. The solution essentially freezes time while protecting biological materials in the cryopreservation process. X-Therma products extend the viability of cells and tissues from minutes into hours and days, allowing best practices in drug development and manufacturing to occur.
XT-Thrive has now been validated by more than 30 collaborators which include the National Science Foundation, ARMI/BioFab USA, NIH/DoD and The Agency for Science, Technology and Research. XT-Thrive is currently serving as a plug-and-play replacement for the cryopreservation of cells, tissues and blood products. It is not only safer for the precious raw materials that it’s preserving, but it offers the scientific community a more effective solution, saving people and organizations significant time and financial resources.
The world has waited a long time for this type of breakthrough in cryopreservation. Fortunately, the solution is now upon us with XT-Thrive.
