Fujifilm Selected with Six Others in FDA PreCheck Pilot Manufacturing Program

Fujifilm Biotechnologies reports that its commercial-scale cell culture manufacturing facility in Holly Springs, NC, has been selected as one of only seven participants in the FDA’s PreCheck Pilot Program. The program, which also includes Amneal Pharmaceutical, Cellares, Eli Lilly, Kriya Therapeutics, Kyowa Kirin, and Regeneron, is a strategic initiative designed to strengthen America’s pharmaceutical manufacturing capabilities and help accelerate patient access to critical medicines.

“We are honored that our Holly Springs site has been selected to participate in the FDA’s PreCheck Pilot Program,” said Lars Petersen, president and CEO of the company. “We’re committed to helping our customers bring life-changing therapies to patients faster, and participation in this initiative will help support greater access to critical medicines in the U.S.”

The pilot program is designed to enhance FDA-industry engagement by facilitating earlier interactions to minimize uncertainty associated with manufacturing readiness, with the goal of creating a more efficient regulatory review process, and strengthening the resilience of the U.S. pharmaceutical supply chain. The FDA PreCheck Pilot Program will focus on manufacturing readiness, regulatory predictability, and expedited facility inspections.

Fujifilm’s customers at the Holly Springs site includes argenx, Johnson & Johnson, Regeneron, and a number of other pharma firms. On behalf of its customers, Fujifilm’s Holly Springs site manufactures monoclonal antibodies (mAbs), including treatments for complex diseases.

Fujifilm’s Holly Springs facility is one of North America’s largest end-to-end cell culture biopharmaceutical manufacturing facilities and represents a key node in the company’s growing global manufacturing network, according to Lars Petersen. The $3.2 billion manufacturing site opened with a capacity of 8 x 20,000 L mammalian cell culture bioreactors, and will add a drug product line in early 2027, followed by Finished Goods. An expansion is underway to double drug substance capacity with an additional 8 x 20,000 L bioreactors.

With an increase in demand for U.S. manufacturing capacity, Fujifilm officials say they will accelerate the opening of its expansion by six months, targeting late FY2027. The Holly Springs site recently surpassed 800 employees, with the overall goal of hiring a total of 1,400 local employees by 2031.

Designed with standardized platforms and advanced digital capabilities, the site is part of the company’s interconnected kojoX^TM operating system, which harmonizes systems, equipment, and processes across global sites to enable faster technology transfer, greater manufacturing flexibility, and consistent quality for customers worldwide

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