NEWTON, Mass. - BostonChron -- Great news for both the bioprocessing industry and the healthcare consumers it serves: The Xheme Multifunctional Additive (XMA), a programmable non-toxic nanoporous microparticle, has demonstrated the ability to significantly reduce or eliminate the damage of oxidative stress in bioproduction conditions.

The bioprocessing industry, with its $21.9 billion market size, plays a crucial role in delivering life-saving biopharmaceuticals and biotherapeutics to patients worldwide. However, the manufacturing of these therapies often faces challenges, leading to reduced yields and increased costs. An imbalance of free radicals and antioxidants known as oxidative stress regularly reduces the yield of pharmaceuticals and therapeutics produced via bioprocessing by about 10-15%.

That's where the unique technology of XMA comes in. A non-toxic, programmable nanoporous microparticle that also possesses antioxidant and antimicrobial properties, XMA acts as a scavenger of reactive oxygen species (free radicals), reducing or eliminating the damage to biomolecules during bioprocessing.

Impact on Bioprocessing

In testing conducted by the Institute for Applied Life Sciences' Cell Culture Core Facility at UMASS Amherst and O2M Technologies, XMA demonstrated superior performance compared to current bioprocessing antioxidants.

"We developed and executed methods that explored high and low levels of XMA powder under growth conditions similar to bioproduction," said Michael Daley, Cell Culture Director at UMass Institute for Applied Life Sciences which provided hands-on technical expertise in evaluating the effect of the additive.

"The XMA-incorporated polyethylene film showed the ability to significantly increase cell viability by about 15% compared to the control after 48 hours," continued Mrignayani Kotecha, PhD, Founder and CEO of O2M Technologies, an oxygen imaging company located in Chicago.

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Additionally, XMA demonstrated a dose dependent enhancement of cell proliferation of roughly 50%. The additive also has antibacterial activity, protects against gamma, x-ray, and UV radiation, and exhibits excellent biocompatibility with cells, leading to improved upstream bioprocessing results.

"These findings suggest that XMA-based cell culture media, bioprocessing bags, and trays will enable a significant increase in the yield and quality of the biologics produced," concluded Daley.

"XMA is unlike any other additive being used in bioprocessing today," explained Kumar Challa, Co-Founder, President, and Chief Scientific Officer of Xheme. "Unlike current anti-oxidants, which are either free-radical scavengers or remove peroxides, XMA is holistic—performing both functions. XMA is also regenerative, which other anti-oxidants are not, meaning less needs to be used for a better result."

"The increase in yield and quality could result in lower bioprocessing cost, which could then be passed on to consumers as savings."

Advancing Drug Discovery and Cell Therapies

In addition to its impact on bioproduction, XMA holds great promise in accelerating drug discovery and reducing animal testing, aligning with the global trend of seeking alternatives to animal models. The use of 3-D organoids, grown from human and animal organ tissues, has gained traction in drug development due to their ability to replicate laboratory animal responses and simulate human body environments. However, oxidative stress and inadequate oxygenation of interior cells pose significant challenges to the widespread adoption of 3-D organoids.

XMA offers a potential solution to these obstacles. By adding XMA to tissue culture equipment or directly into the growth matrix, oxidative stress can be eliminated, and the interior cells can be adequately oxygenated.

"Using hydrogen peroxide to cause oxidative stress in a cellular model," said Riccardo Amorati, PhD, an Associate Professor in the Department of Chemistry at the University of Bologna, Italy who has worked with Xheme on previous studies, "we showed that XMA-incorporated films converted damaging peroxides into oxygen and water."

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This breakthrough has the potential to revolutionize the soon-to-be $5.6 billion 3-D organoid industry and expedite the development of safer and more effective therapies.

Furthermore, the studies conducted on HEK293F and human blood cells showed that XMA is not toxic in large doses, up to a concentration of 10,000µM and 100µM, respectively. Further testing is underway to determine potential toxicity, if any, at higher concentrations.

Revolutionary Potential

The XMA breakthrough technology could bring about significant changes in the industry, benefiting both healthcare consumers and manufacturers.

Lowering the cost of bioprocessing and the development of cell therapies through the use of XMA could result in more affordable live-saving treatments for patients. Additionally, the improved quality and safety of therapies produced with XMA could have a profound impact on the outcomes of various conditions treated with cell therapies, including diabetes, Parkinson's disease, Alzheimer's disease, and cancer.

"XMA is a game-changing technology," noted Paul von Kirchbach, an Xheme Advisory Board member and an international expert on sustainable polymers. "Xheme is currently discussing with business partners and various biotech companies about testing XMA in bioprocessing products. The impact of this discovery on the biotech industry will be revolutionary."

About Xheme, Inc.
Xheme, Inc. is a specialty materials company based in Newton, MA. Xheme is working to revolutionize the world of plastics and coatings applications by eliminating the need for single-use/single-function additives by using one programmable additive that provides the same, or better, performance. From bioprocessing bags to paints, the non-toxic Xheme Multifunctional Additive (XMA) provides a combination of four protections—from oxidation, UV, corrosion, and microbial contamination—and is safe for both people and the planet. Xheme has a robust intellectual property portfolio and is transforming discovery of next generation smart additives through collaborations with global academic and industry leaders. For more information, visit xheme.bio and follow us on LinkedIn.