Astellas Pharma Inc. announced the opening of a new late-stage clinical and commercial manufacturing facility in Sanford, N.C. The facility will allow the company to expand its resources and team to establish a robust, global supply chain and expand its therapeutic and geographic scope.
"Our new manufacturing facility symbolizes our company's continued dedication to the advancement of novel life-changing gene therapies for patients with severe diseases and a significant unmet need, as well as our commitment to the Sanford community," said Mathew Pletcher, Ph.D., Senior Vice President and Division Head of Gene Therapy Research and Technical Operations at Astellas Gene Therapies.
"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. This new facility is a key enabler of our mission to develop safe, effective, and transformative gene therapies as swiftly as possible. As such, Sanford's manufacturing capabilities will allow us to produce materials for multiple programs in parallel as opposed to in sequence and offer commercial-scale manufacturing ability to any future approved therapies. This is critical to rapidly advance our programs and drive the next phase of growth for Astellas."
Through the expansion of Astellas' integrated global manufacturing infrastructure, the company is working to increase its manufacturing capabilities and achieve greater scalability and affordability for gene therapies. The Sanford facility enables continual learning and efficient knowledge-sharing, helping to improve the pace and effectiveness of drug development. The 135,000 square-foot standalone facility will be good manufacturing practices (GMP) compliant and is designed to provide clinical- and commercial-scale manufacturing capabilities for Astellas' pipeline of AAV gene therapies.
The company's $100 million investment will also support global supply chain needs and in-house quality control testing, as well as the creation of more than 200 jobs through 2026. The new facility located at 6074 Enterprise Park Drive joins the vibrant biopharmaceutical research and manufacturing community established in Lee County.
"Sanford, North Carolina is a premier location for Astellas Gene Therapies to expand its manufacturing operations," said Governor Roy Cooper. "Our state's skilled workforce, leading academic institutions and healthy business environment provide all the resources they need to foster innovation and continued success."
With the establishment of the Astellas Gene Therapies Center of Excellence following the 2020 acquisition of Audentes Therapeutics Inc., Astellas is a leader in genetic medicines, working alongside its world-renowned partners to build a portfolio of potentially life-changing gene therapies. Astellas strives to identify, develop and deliver transformative therapies for patients with genetic diseases who currently have few or no effective treatment options.