The preservation of living cells and tissues is an often-underappreciated obstacle in the clinical lab. Cryogenic temperatures attempt to address this challenge by minimizing biochemical activity within samples of interest. As the cell and gene therapy market grows, the drawbacks of cryopreservation are becoming more apparent.

This article examines the current cryopreservation landscape within the cell and gene therapy market and explores emerging solutions to meeting supply demands and patient safety standards

Find the whole article here:  Today’s Clinical Lab

This article is taken from X. Wei, PHD, “Taking the Toxins Out of Cell Therapy Storage: A New Cryopreservation Molecule,” Today’s Clinical Lab, June 14, 2022

X-Therma Inc., a biotechnology company developing breakthrough technology for regenerative medicine and organ preservation – announced today that The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has granted its proprietary organ preservation solution, XT-ViVo®, and TimeSeal® Organ Transport Device, Breakthrough Device status. This designation is granted to products that have the potential to offer more effective diagnosis or treatment of life-threatening diseases with an unmet medical need.

“This milestone moves us as a company, and more broadly as an industry, one step closer to tackling the organ shortage problem,” says Dr. Xiaoxi Wei, CEO & Co-Founder of X-Therma. “With less than 10 percent of the worldwide demand met for transplantable organs, being able to remove time barriers for safe and reliable organ preservation, without changing the peri-transplant workflow, is a game-changer and, we envision, will prove to be a lifesaver for all of those in need.”

XT-ViVo® is a novel organ preservation solution indicated for perfusion and flushing of a donor’s kidney prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation to the recipient.

TimeSeal® Organ Transport Device is designed for static hypothermic preservation of adult donor kidneys during transportation and subsequent transplantation into a recipient using XT-ViVo®. The anticipated debut of this device into the market has the potential to provide extended organ storage time for up to 120 hours. Donor kidneys that exceed clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.

“Paired together, our technology will extend the time for organ transport while minimizing ischemic damage and consequently increase the global availability of organs, expand the organ pool, and improve donor-recipient matching as well as elective surgery scheduling,” says Dr. Mark Kline, CTO & Co-Founder of X-Therma.

The Breakthrough Device program is designed to enable accelerated development, assessment, and review processes, with the intention to provide patients with more timely access to breakthrough technologies or devices. This program also offers manufacturers an opportunity to interact with the FDA’s experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way.

About X-Therma Inc.

X-Therma is headquartered in Richmond, part of the San Francisco Bay Area, with research centers in Richmond and Berkeley, and now has expanded to Austria in Europe. X-Therma pioneers ground-breaking cold chain technology via a convergent biopreservation platform, to advance Regenerative Medicine and make available safe and on-demand organs, engineered tissues, cell & gene therapies, vaccines, and beyond to patients in need. X-Therma’s technology could be a paradigm shift that makes worldwide organ sharing possible and eliminates organ waiting lists across the globe. X-Therma has been a selected Industrial User at the Lawrence Berkeley National Laboratory and received over $11M contracts and grant support from the U.S. Department of Defense, the National Science Foundation, and the California Institute for Regenerative Medicine. The company recently closed an oversubscribed Series A of $13M.

Every day it seems you can find a headline somewhere describing the extraordinary progress scientists have made in developing cell and gene therapies for rare genetic diseases, a variety of cancers, and common ailments that affect most of the industrialized world. Genetic material is now common in vaccines, too, as scientists discovered that mRNA is an effective starting point for eliciting a strong immune response to SARS-COV-2. But besides their genetic components, all these medical products face a common challenge: they must be kept cold during storage and transport to remain viable until they can be used.

Unfortunately, current techniques for cryopreserving cells and tissues are not built to preserve medical products. But today, scientists and engineers are developing new tools such as protein-like “peptoids” that can make cold storage and transport easier, safer and more reliable.

Find the whole article here:  Technology Networks

This article is taken from Technology Networks | By Xiaoxi Wei and Mark Kline | Apr 11, 2022

Living cells, tissues, and organs are more critical to medicine than ever before, but current cryopreservation techniques are not enough to keep these materials viable during storage and transport. Peptoids may provide the solution.

Find the whole article here:  European Biopharmaceutical Review | April 2022

This article is taken from European Biopharmaceutical Review April 2022, pages 48-51. © Samedan Ltd