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New Member Spotlight: Akron Biotech

“At Akron Biotech, we’ve been collaborating closely with ARMI |BioFabUSA members on exciting projects since we first joined,” says Dr. Claudia Zylberberg, CEO of the company.

Akron Biotech, a privately-owned company founded in 2006 by Claudia Zylberberg, PhD., began as a distributor of raw materials and components for the biotechnology industry. Over time, it recalibrated its product portfolio, bolstered its quality systems, and expanded its core capabilities in order to serve clients in the regenerative medicine industry.  Akron has grown to become a leading manufacturer of ancillary materials and purveyor of specialized services with aimed at accelerating the development and commercialization of advanced therapies.

The company manufactures and commercializes ancillary materials from research grade to cGMP grade, supporting its customers from bench to bedside. This enables cell and gene therapy developers as well as tissue engineering companies to maintain compliance with complex and evolving regulatory requirements across borders while also containing their cost of goods.

Among Akron’s core capabilities is cryopreservation. According to Dr. Zylberberg, “It is critical to ensure cell viability and functionality through the complex supply chain involved in the production of advanced therapies, which is why Akron has focused on the development and commercialization of innovative cryopreservation media.” Akron is committed to pushing the technology frontier in the preservation of cells and tissues, enabling their storage and transport across large distances.

 “We love challenges. Our employees include scientists, ‘intrapreneurs,’ and quality control and assurance specialists, as well as sales, marketing, manufacturing, and operations professionals. Everyone works together to support the advancement of novel therapies,” noted Dr. Zylberberg, adding, “Every day, our employees tackle big questions in new and creative ways—whether they relate to discovery, quality, or manufacturing — we bring this inquisitive spirit into everything we do, including our ARMI projects.”

Recently, Akron Biotechnology partnered with Marsha Rolle, associate professor of biomedical engineering at Worcester Polytechnic Institute (WPI), who is also an ARMI member, to develop a novel cryopreservation media to support the storage and transport of manufactured tissues.  The project furthers ARMI’s mission of enabling the large-scale production of engineered tissues and tissue-related technologies. Specifically, Rolle and Akron will develop dimethyl sulfoxide (DMSO) - free cryopreservation media. DMSO has long been used as a cryoprotective agent for cells and tissues; however, it is known to be cytotoxic, alter cell behavior, and have negative clinical side effects, leading many in the industry to seek novel, alternative solutions.

"ARMI has been an excellent forum for convening diverse sets of skills from industry and academia to forge new connections. It is essential that we bring together the right people in order to foster this new and exciting industry," says Dr. Zylberberg, continuing, "We are very excited about our strategic partnership with WPI aimed at developing cryopreservation media to serve the expanding tissue engineering and regenerative medicine (TERM) industry."

Beyond cryopreservation media, Akron develops and manufactures scaffolds and recombinant proteins critical in the production of engineered tissues.

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“We became deeply involved with ARMI very early on,” commented Dr. Zylberberg adding, “We are also involved with NIIMBL (another Manufacturing USA Institute) as well as other public-private consortia, so we are very comfortable in these settings. Partnering and building strategic alliances with life science organizations and institutions are vital to Akron.”

Akron has long understood that its own success depends on the industry’s success. For this reason, the company has long been involved in efforts to standardize the manufacture, transportation, and storage of advance therapies and the ancillary materials required to produce them. These efforts have meant meaningful and productive engagement with organizations like the U.S. Food and Drug Administration (FDA), the International Organization for Standardization (ISO), the Alliance for Regenerative Medicine (ARM), and the Standards Coordinating Body (SCB), to name a few.

“The keys to Akron’s commercial success include our ability to identify industry bottlenecks and calibrate our product strategy to resolve them, our active participation in the development of industry standards and our deep understanding of the shifting regulatory landscape, and lastly but perhaps most importantly, our dedication to manufacturing the highest quality ancillary materials on the market at a competitive cost,” noted Dr. Zylberberg.

“In the last two years, we’ve seen the FDA approve some of the first gene therapy products and I feel that the best is yet to come. At Akron, we will continue to ensure that all of our products are produced safely and in a cost-effective manner so that they can help transform medicine and save lives.” For more information, visit Akron Biotech’s website!