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Xheme and Vitalant Research Institute partner on new non-toxic, non-PVC blood bag technology

Amzeal News/10553978
Xheme, Inc.
The novel blood bag film technology promises to increase shelf life of blood and meets upcoming EU requirements.

NEWTON, Mass. - Amzeal -- Xheme, Inc., a specialty materials company developing eco-friendly multifunctional technologies that reduce or eliminate oxidative stress, and Vitalant Research Institute (VRI), a leading transfusion medicine research institute and an integral part of Vitalant, the nation's second largest blood services provider, are developing a non-toxic, non-PVC film technology that promises to conserve scarce blood supplies and meets upcoming European Union regulatory requirements for medical plastics.

Most plastic blood bags used today are made from polyvinyl chloride (PVC) and a plasticizer called DEHP, or di(2-ethylhexyl) phthalate. While it keeps the bags pliable, DEHP also leaches into the blood and helps preserve red blood cells for as long as 42-days in refrigerated storage. At the same time, recent studies have shown that DEHP plasticizers are carcinogenic endocrine disruptors and PVC disposal releases chlorine-based chemicals into the air, water table, and food chain.

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Currently, governmental bodies in Europe and the United States are looking to ban the use of both DEHP and PVC, with the European Union giving its industries until 2030 to remove the plasticizer. However, with the global blood shortage standing at 30 million units per year, the transition away from DEHP-PVC blood bags is fraught with challenges.

Xheme and VRI are working to overcome those challenges by developing a non-DEHP, non-PVC plastic film technology that can perform to the same level as, or better than, current blood bags in storing whole blood, while also being more biodegradable and biocompatible.

As part of a recently completed National Science Foundation STTR project, co-principal investigators, Kumar Challa, PhD, CEO, President, and Co-founder of Xheme, and Tamir Kanias, PhD, an associate investigator at VRI who specializes in whole blood and red blood cells, found that incorporating Xheme's technology into PVC plasticized with non-toxic DEHT produced a blood bag that meets the established 42-day shelf-life for red blood cells – a significant improvement compared to DEHT-only PVC.

Now, using new NSF-STTR funding awarded at the end of January, the pair will be perfecting a non-PVC version of the technology and its ability to extend the shelf life of whole blood by protecting against cold storage-induced oxidative injury and spontaneous hemolysis — destruction — of red blood cells.

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"With the new NSF-STTR award, we are able to advance the development of much needed next-generation DEHP-free as well as PVC-free blood bags, offering a more permanent solution than what just DEHP-free PVC bags can offer," said Kanias.

"This non-PVC technology marks the first real blood bag innovation since the 1960s," said Challa. "It is non-toxic, environmentally friendly, and keeps blood healthier for longer, potentially saving thousands of lives yearly by reducing the waste of expired donated blood."

This novel technology can seamlessly integrate into current film and bag manufacturing and blood storage infrastructure, and can replace both PVC and toxic plasticizers at the same time — preventing dangerous blood shortages during the transition away from DEHP. It can also be used in the production of non-toxic dialysis bags, IV bags, medical tubing, synthetic blood, and has bioprocessing industry applications.

The technology's commercial potential is great with the global blood bag industry estimated to reach about $845 million by 2033 and biopharmaceuticals about $460 billion by 2025. More importantly, the ability to keep blood healthy for longer periods of time will help address seasonal declines in blood donations and the increased demand for blood products by the United States' aging population.

Co-applicants on a filed patent, Xheme and VRI recently expanded their three-year relationship by signing a joint commercial agreement last month.

Source: Xheme, Inc.
Filed Under: Medical, Health

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