Astellas Ups Production of Gene Therapies With New Carolina Plant

Astellas has announced the opening of a new gene therapy manufacturing facility in Sanford, New Carolina. The plant will produce late-stage clinical and commercial products, and allow the company to expand its therapeutic scope as well as establish a robust, global supply chain. 

“This state-of-the-art facility builds on our existing manufacturing network in Tsukuba, Japan, and South San Francisco, California, and will serve as a major driver of our pipeline, partnerships, and technology,” said Matthew Fletcher, PhD, Senior Vice President and head of the Gene Therapy Research and Technical Operations division at Astellas Gene Therapies. 

Sanford’s manufacturing capabilities will allow the company to produce materials for multiple programs in parallel as opposed to in sequence, and offer commercial-scale production for future approved products, he added. 

Related article: Astellas Ditches Gene Therapies, with Losses Exceeding $390 Million 

Specs Provided by Sanford 

The fruit of a $100 million investment from Astellas, the 135,000 square-foot Sanford facility will be GMP-compliant and produce clinical and commercial AAV gene therapy products. 

Besides supporting global supply chain needs and in-house quality control testing, the plant is expected to add more than 200 jobs through 2026. According to the company, about 50 employees currently work at the site, which is still awaiting an approval from the US FDA to begin commercial production. It is located at 6074 Enterprise Park Drive, joining the likes of Pfizer and Abzena, a CDMO, in Lee County. 

Sanford is part of the Astellas Gene Therapies Center of Excellence, created after Astellas acquired San Francisco-based Audentes Therapeutics in 2020. 

Going Live Despite Setbacks

The opening of a new plant comes as Astellas reassesses its gene therapies, which have suffered clinical setbacks in recent years. 

The company had to redraw plans for its lead candidate for X-linked Myotubular Myopathy (XLMTM), AT132, after four patients died from complications linked to the gene therapy. Moreover, the company in April chose to terminate development on three other gene therapies based on “recent preclinical study data”.

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Joy Lin

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