“It is a new and better way to grow and manipulate cells in vitro. It goes beyond the needs of people, to meet the needs of cells,” exclaimed Randy Yerden, founder and CEO of BioSpherix, adding “You could say Cytocentric® is a philosophy, and in some ways it is. It certainly includes an unusually hefty reverence for cells. Our new approach to cell culture and processing is based on a lot of hard science, much of which is brand new and currently unfolding in hundreds of labs around the world.”
In 2014, BioSpherix Medical®, located in Parish, NY, was spun out of its predecessor to accommodate the demand for GMP compliant cell production equipment for cell/gene therapies. Since founding in 1982, BioSpherix, Ltd. has focused exclusively on research equipment, which is still sold to academic, medical research centers, pharmaceutical, biotechnology, and governmental research organizations throughout the world.
“Ironically today’s technology is affirming old knowledge about cells; but now in a more disciplined quality approach. Somehow some of this knowledge had faded after decades of putting up with equipment designed for people instead of cells,” he said.
Yerden discussed the BioSpherix platform explaining, “It’s an extremely modular, infinitely configurable, closed and optimized ecosystem for cells. It is designed to configure around and therefore fit any cell production process, simple or complex, large or small, manual or automated for any type of machine. It also neutralizes typical negative effects of machines on cells and yet still gives maximal access to those machines.”
“We learned about ARMI from another member when we attended a session in Boston, and when we understood that ARMI was all about bringing experts together for the same end game, we knew immediately we needed to be a part of that,” Yerden continued, “The tremendous promise of manufactured cells alleviating such a massive amount of human pain and suffering just has to be realized. And success will be contingent upon the highest standards set early in the development of the Regenerative Medicine industry. That’s where we can assist ARMI Members.”
The company’s Cytocentric® protects cells inside with fully aseptic conditions regardless of the air quality outside. “No longer will ARMI Members have to worry about processing virus, vectors, off-target gene edited cells, or contagious pathogens in diseased patient’s cells or have to settle for cell exposure to non-aseptic ISO 5 air, or worse.”
“Ideally we have built the ecosystem that cells should never have to leave. That’s why we keep striving to fill every gap in cell existence outside the body, from explant to implant and all points in between. We aren’t there yet, but we’ve never failed to fill a new gap that a customer needs to fill for the sake of their cells. It keeps adding to our library, and we welcome all newcomers.”
Yerden and his team at BioSpherix are particularly proud of an illustrative case. A hospital had no GMP facilities but within six weeks a BioSpherix Xvivo System® was moved to the Illinois hospital’s surgical suite, where it was installed and validated. Under FDA approval, it produced a synthetically bioengineered trachea using the patient’s own cells. In the adjacent surgical suite, within minutes after production, the trachea was successfully implanted in a two-year old child born with tracheal agenesis, a rare congenital condition that causes the underdevelopment or absence of a trachea in newborns.
“This proves Regenerative Medicine can take place in any hospital,” Yerden noted. He continued, “Aspiring cell therapists are no longer dependent on the limited number of multimillion dollar clean rooms, usually only found distances from the clinics where the sick patients are located. They can produce clinical grade cells wherever they practice.”
When asked about challenges in the RM industry and for his company, Yerden said, “I hope that our ARMI membership gives us a forum to fully reveal the substance and versatility of the platform. A challenge has been skepticism about regulatory compliance. Although it is perfectly aligned with 21st Century GMPs, and although the regulatory agencies themselves seem to love it, and it is passing every “official” regulatory milestone and scrutiny all over the world, most so-called “GMP experts” assume it won’t comply and can’t be used in GMP just because it’s unconventional
“Regenerative Medicine (RM), stem cells, tissue engineering, gene therapy, adoptive immunotherapy, assisted reproduction, bone marrow transplantation, islet transplantation and all the other new clinical applications of cells are destined to change the landscape of medicine,” Yerden noted, “Look closely and you'll see that the our approach is the only quality option, whether you use our equipment or not. The stakes are too high, and regulatory agencies will eventually agree. The needs of your cells must be met in order to endow them with maximal genotypic and phenotypic integrity and minimal variability, the best ones to use in patients. And, it makes everything easier and less expensive!” he exclaimed.