The addition of a biomanufacturing plant in Florida will support the high demand for Akron Biotech’s cytokine and media products from the blossoming cell and gene therapy sector.
Akron Biotech has expanded its operations by acquiring a biologics facility in Sarasota, Florida second manufacturing plant. The firm makes cGMP-compliant cytokines that are embedded in numerous clinical and commercial cell therapies and the addition of a second facility is needed to expand capacity to meet the tremendous demand, according to Akron spokesperson Ezequiel Zylberberg.
While this is being driven by “high demand for cGMP-compliant ancillary materials to support the burgeoning cell and gene therapy market,” the firm is also seeing step-change demand increases from existing customers as they advance into phase 3 and commercialization.
“In fact, some customers are indicating their forecasted volumes will grow in excess of 10x their current demand in a few years,” he told Bioprocess Insider.
“Our cGMP-compliant cytokines are embedded in numerous clinical and commercial cell therapies. While most cytokine manufacturers have grown alongside the industry, upgrading from the production of research-grade cytokines to cytokines manufactured under cGMP compliance, Akron has addressed the need for these critical materials differently, ultimately allowing us to provide the highest quality cytokines on the market.
He continued: “We manufacture our IL-2, IL-7, IL-15, and IL-21 among other recombinant proteins at gram scale utilizing pharma purification processes (SEC/TFF), and have several electronic Drug Master Files in place and forthcoming to ensure that our customers have the support they need when engaging regulatory agencies.”
The 60,000 square-foot biologics facility in Sarasota, Florida was acquired from Cambryn Biologics, though financial details of the deal have not been disclosed. The plant, commissioned in 2012, was a plasma fractionation facility but will be repurposed for Akron’s use and is expected to be operational later this year.
“The Sarasota site is an established cGMP-compliant biologics manufacturing plant with state-of-the-art equipment and a highly capable pre-existing workforce,” said Zylberberg. “With only minor adaptations, this plant will allow us to rapidly scale our existing products such as cGMP cytokines and media, while also establishing new lines of business such as cGMP plasmid manufacturing.
“The new facility will also provide significant shell space, thereby allowing us to scale rapidly to support our customers from development through to commercialization.”