A plasmid DNA manufacturer is planning to scale up its production capacity to meet the growing needs of gene therapy. Aldevron, a company based in North Dakota, expects to open a new 189,000 sq. ft facility in spring 2021 to add to their existing 70,000 sq. ft of manufacturing space.

“We currently have the biggest GMP plasmid facility in the world,” explained Michael Chambers, executive chairman and co-founder of Aldevron, in an exclusive interview with GEN. “We’re really excited to be adding to that.”

The new facility will be GMP grade and part of the company’s journey to increase overall capacity for plasmid DNA production by 10x, said Kevin Ballinger, who joined the company as CEO last month.

“This is a special company and an interesting proposition,” Ballinger added. “There aren’t many industries where there is currently more world-wide demand than capacity.”

DNA plasmids are increasingly required in large quantities for gene therapy applications, Chambers explained. The new facility, which can manufacture plasmids for human clinical trials, including Phase III trials, and commercial products, will help overcome the current massive bottleneck in global production, according to Ballinger.

“Many leading COVID-19 vaccine candidates are RNA vaccines, which require plasmids to manufacture the RNA via transcription processes,” added Chambers. “So, if we’re going to make one billion vaccines, that requires just over half of the world’s available plasmid manufacturing for that one product.”

In addition to COVID-19 vaccine candidates, new viral-based gene therapies are coming online. There are currently eight or nine gene therapies approved by regulators that require plasmids as part of their manufacturing process or have plasmids as their active ingredient, pointed out Chambers.

As of September 2019, there were also over 2,000 in human clinical trials worldwide. “So, these clinical trials are consuming a lot of plasmids and viral vectors,” Chambers said. He expects this number only to grow as successes in diseases like Duchenne muscular dystrophy encourage the development of therapies for diabetes or heart disease.

Aldevron is aiming to increase plasmid yield and cut costs by building new E. coli cell lines specifically for plasmid manufacturing. They are also developing membranes with improved ability to purify plasmid DNA.

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