Akron Bio debuts new plasmid DNA plant on quest to ease regenerative medicine bottlenecks

As cell and gene therapies, mRNA vaccines and other cutting-edge meds come into their own, developers have put a strain on the industry's supply chain. That’s where biopharma building block outfits like Akron Bio come in.

Akron, which designs and makes materials for the regenerative medicine industry, has cut the ribbon on a new plasmid DNA manufacturing facility in Sarasota, Florida, where the company plans to enlist more than 100 staffers by the end of 2022.

The plant will help “address critical bottlenecks in the rapidly growing gene therapy and vaccine markets by providing cGMP-quality plasmid DNA, a critical ancillary material for advanced therapies that will improve lives worldwide,” Akron told Fierce Pharma.

That extra supply is critical as the pipeline of advanced therapies—products like cell and gene therapies and certain vaccines—grows increasingly crowded, the company noted in a release.

As of 2021’s third quarter, 2,261 regenerative medicine trials were taking place around the globe, Akron said via email, citing the Alliance for Regenerative Medicine. What's more, 2022 could be a “banner year for gene therapies for rare diseases," Akron said over email.

Akron is keeping its plant investment close to the vest, though it said “[c]osts are aligned with those for construction of a full cGMP facility.”

So far, the company has built out 54,000 square feet of its new 110,000-square-foot development and manufacturing site. The ribbon cutting represents the first step in a multiphase opening, Akron said.

The plant is equipped with multiple clean rooms plus process development and quality control labs for scale-up, tech transfer and method development, the company said. It also boasts an in-house quality control lab with a “full suite” of plasmid DNA-focused analytical development and validation capabilities.

Plenty of others in the manufacturing and supply space have been plugging into plasmid DNA in recent years. Take Thermo Fisher Scientific, for example, which opened a 67,000-square-foot plasmid DNA plant in Carlsbad, California, last July. The site is designed to tackle clinical and commercial production of plasmid DNA used in cell and gene therapies for cancer plus mRNA vaccines, as well as large-scale manufacturing of plasmid DNA as a primary drug substance for DNA therapies, the company said in a December 2020 release.

Like Akron, Thermo Fisher stressed that the meteoric rise of cell and gene therapies and next-gen vaccines was outpacing supply of commercial-quality plasmid DNA.

"Our new state-of-the art site will not only tackle the supply bottleneck for our customers but also uniquely positions us to deliver robust, end-to-end cell and gene therapy capabilities,” the company said at the time.