Astellas joins Pfizer in emerging North Carolina hub, unveiling new $100M gene therapy manufacturing site

08 Jun 2022
endpts.com
Gene TherapyAcquisition
The small city of Sanford, NC, was once known for its brick production, but now is quickly becoming a hub in the biotech world. And now Astellas is the latest to pitch its tent in the area. The company’s gene therapy branch, which came out of the acquisition of Audentes in 2019, has opened a new manufacturing facility in the city, comprising 135,000 square feet and shelling out $100 million. Astellas designed the site to provide clinical and commercial-scale manufacturing capabilities for its pipeline of AAV vectors for gene therapies, which includes programs from both Astellas and Audentes’ portfolios. Wednesday’s 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. Currently, around 50 people are already employed at the site. Mathew Pletcher, division head of gene therapy research and technical operations at Astellas, said that Sanford is a good location because it can provide enough space for the initial build, but is also large enough for any future expansions if needed. Pletcher also said this move puts Astellas in an area that is quickly becoming a major hub for genetic medicine and manufacturing. Its new facility is just down the road from a 230-acre Pfizer manufacturing site that has been heavily investing in gene therapy capabilities, according to a report from NCbiotech. In 2021 , Abzena also selected Sanford for a $200 million biologics plant that will eventually house around 24,000 square feet of bioreactor capacity. “This area of North Carolina is quickly becoming a hub of genetic medicine and manufacturing, and so you can look at it two ways. Yes, that creates some competition for the workforce, but it also speaks to the fact that now there is a real nucleus of expertise being generated,” Pletcher said. As to why Astellas felt it needed the plant, Pletcher said the company recognizes that AAV manufacturing remains a choke point for the industry, stating there are still limitations when it comes to both capability and capacity. And as Astellas moves its therapies toward the clinic, the company will need more access to clinical-grade material that can support a global rollout. “Just to make the material… at cost and to meet the goals and the needs of our growing portfolio, we were going to need more than what we had in South San Francisco,” he said. Pletcher also noted the new facility places Astellas near major collegiate institutions such as Duke and the University of North Carolina. While no formal relationships have been forged, Pletcher hopes to leverage this connection to both identify talent and possibly forge more academic partnerships. And while the company is committed to its new location, their South San Francisco facility will continue to play a major role. Sanford will focus primarily on clinical supply and eventual commercial supply, while the California site can work to help support its early portfolio, as it is closer to the cell and gene therapy research hub. Pletcher sees the new plant as not just a way to roll out gene therapy elements, but as a way to engage the biotech industry as a means to partner with smaller companies. “The scale and the scope of the investment that Astellas is making in gene therapy, as represented by this facility, just speaks to its commitment to the space and the vision of the importance of gene therapy and the future of medicine,” he said. “And then ultimately, what this site allows us to do is to think globally, to think broadly, to think about where we can take our portfolio and platform without having some of the limitations that I think, particularly in the biotech space, really squeeze a lot of those companies.”
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