Medical Device Network

X-Therma sees FDA Drug Master File acceptance

The FDA acceptance means that clients who use X-Therma’s cell preservation tech can include these as part of new drug applications.

San Francisco-based organ preservation company, X-Therma, has announced that the US Food and Drug Administration (FDA) has accepted its Drug Master File (DMF) for XT-Thrive, a product designed for the cryopreservation of drugs and organs.

X-Therma submitted the DMF to the FDA in January 2024 for its cryopreservation system, enabling the preservation of mammalian cells at ultra-low temperatures ranging from -70c to -196c and designed to avoid the formation of ice and any resulting damage to preserved cells. The company has said it is intended for the cryopreservation of cells used in the manufacture of products including monoclonal antibodies, recombinant proteins, fusion proteins, and vaccines.

As a result of this DMF acceptance, X-Therma clients who use the product to preserve therapeutic cells will be able to reference the DMF in their Investigational New Drug (IND) and Biologics License Application (BLA) submissions to the FDA for products in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

Michael Osborne, vice president of commercialisation at X-Therma, said: “XT-Thrive is tailored to provide high cell recovery and functionality that poses many advantages over other products on the market. It is the plug-and-play solution for cell and tissue manufacturing processes to enable greater bioproduction scale-up, reliability, and consistency."

Previously in March of this year, X-Therma was able to acquire $22.4m in Series B funding aimed at pushing its products to market including its XT-ViVo organ preservation solution and TimeSeal organ transport device are being developed for the storage and transport of transplant organs.

The market for cell and organ preservation, often without the use of direct freezing methods such as using iceboxes, has been a rapidly growing market in the US with a number of companies making moves into the space, including the Massachusetts-based Paragonix in 2023 debuted its newest organ preservation transporting a liver between the US mainland and Puerto Rico.

Elsewhere in the market, the UK-based OrganOx raised £25m ($32m) to develop its normothermic machine perfusion (NMP) device that preserves donor livers in a functioning state for up to 24 hours before transplantation.