Audentes $109m NC expansion boon for Astellas gene therapy plans

Astellas acquisition Audentes has laid plans to build a 135,000 square-foot gene therapy manufacturing plant in Sanford, North Carolina.

The $109 million (€100 million) plant is expected to be operational in 2021 and will support Audentes’ gene therapy portfolio. The firm’s lead product is AT132, a Phase I/II clinical-stage experimental treatment for X-linked myotubular myopathy (XLMTM), though the firm is also developing gene therapies for Pompe disease and Duchenne Muscular Dystrophy (DMD).

“Our investment in large-scale manufacturing has always been a cornerstone of our strategy to develop and ultimately deliver our important genetic medicines to patients as rapidly as possible,” Natalie Holles, CEO of Audentes, said.

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“This new facility in Sanford will support the next phase of our growth as we establish a robust, global supply chain.”

The Sanford plant will accompany a multi-product adeno-associated virus (AAV) manufacturing plant in San Francisco boasting a GMP suite with two 500-liter bioreactors for use with the company’s serum-free suspension cell culture-based production system. It is also the latest example of the firm expanding its network, having opened a GMP plasmid manufacturing facility – also in San Francisco – in April last year.

The investment also helps further demonstrate the ambition of Audentes’ owner, Astellas. The Japanese pharma firm bought Audentes for $3 billion only two months ago, citing Audentes’ manufacturing network as a way to reduce reliance on third-party manufacturers.

The deal followed the acquisition of UK-based preclinical biotech Quethera in August 2018, giving Astellas an initial foot in the gene therapy door.

North Carolina has been a biopharma center for decades, particularly in R&D, but Sanford, Lee County is growing into somewhat of a gene therapy manufacturing hub. Audentes joins Pfizer, which constructed a site in Sanford in 2017. In August last year, Pfizer ploughed in $500 million to expand recombinant AAV vectors capacity for use in its gene therapies and vaccines.

“Audentes Therapeutics is joining one of the nation’s top life science clusters,” said North Carolina commerce secretary Anthony Copeland. “North Carolina has the largest biomanufacturing workforce in the nation and a growing concentration of gene therapy scientists, researchers and workers.”