Astellas Opens New US-based Large-Scale Gene Therapy Manufacturing Facility

On June 8, 2022, Astellas Pharma announced that it has opened its new late-stage clinical and commercial manufacturing facility in Sanford, NC. The new 135,000-ft2 facility is a standalone facility that is good manufacturing practices compliant. It is designed to provide clinical- and commercial-scale manufacturing capabilities for the company’s pipeline of adeno-associated virus (AAV) gene therapies.

The company's $100 million investment in the site will support global supply chain needs and in-house quality control testing. The investment will also create more than 200 jobs through 2026.

"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, PhD, senior vice-president and division head of Gene Therapy Research and Technical Operations at Astellas Gene Therapies, in a company press release. "This state-of-the-art facility builds on our existing manufacturing network in Tsukuba, Japan, and South San Francisco, Calif., 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."