Akron Biotechnology, which develops and manufactures cGMP-compliant cytokines and other ancillary materials to enable cell and gene therapy development and commercialization, reports that it will expand to a second manufacturing facility in the U.S. Akron Biotech has acquired a 60,000-square-foot biologics manufacturing site in Sarasota, bolstering the company’s U.S. capacity. The site will be operational later this year.

“We are expanding to meet the growing demand for validated, cGMP-compliant materials as the regenerative medicine and advanced therapy industry moves more and more products through late-stage clinical development and towards commercialization,” explained Claudia Zylberberg, PhD, founder and CEO of Akron Biotech. “The new site will enable us to scale up our production capacity while remaining committed to providing our customers with high-quality materials that allow them to deliver safe and effective cell and gene therapies.”

According to Zylberberg, the Sarasota site will facilitate rapid growth in each of the company’s three main cGMP business verticals: cytokines and growth factors, growth and cryopreservation media, and viral inactivated human-derived media supplements. It also enables the company to add cGMP-compliant plasmid development and production to its custom development and manufacturing services, addressing one of the central bottlenecks in the cell and gene therapy industry.

Last September, Arcline Investment Management, a private equity firm with $1.5 billion of committed capital, acquired a majority interest in Akron Biotech. Arcline is working with the Akron team to build new capabilities and expand manufacturing capacity, strengthening its portfolio of ancillary materials and development and manufacturing services, explained an Arcline official.

Akron will continue to manufacture its flagship cytokine product portfolio (IL-2, IL-7, IL-15, IL-21, and others) at large scale and under cGMP compliance at its pharmaceutical manufacturing facility overseas. The company will retain its global headquarters and manufacturing facility in Boca Raton, FL. The Sarasota site will be configured to support the production of the company’s cGMP-compliant product portfolio, as well as to scale its media development services in addition to building its plasmid manufacturing capabilities.

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