HOLLY SPRINGS, NC,  FUJIFILM Biotechnologies (Fujifilm), a world-leading contract development and manufacturing organization (CDMO) for biologics, vaccines, and advanced therapies, today announced that its commercial-scale cell culture manufacturing facility in Holly Springs, North Carolina, has been selected as one of only seven participants in the U.S. Food and Drug Administration’s (FDA) PreCheck Pilot Program. The program 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 chief executive officer, FUJIFILM Biotechnologies. “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 enhances FDA-industry engagement by facilitating earlier interactions to minimize uncertainty associated with manufacturing readiness, designed with the hope 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 other leading pharmaceutical companies. On behalf of its customers, Fujifilm’s Holly Springs site manufactures monoclonal antibodies (mAbs), including treatments for complex diseases.

“As our customers continue advancing innovative biologic therapies, manufacturing readiness and regulatory predictability are increasingly important,” said Laurie Braxton, senior vice president and site head, Holly Springs, NC at FUJIFILM Biotechnologies. “Our participation in the program reinforces our commitment to providing customers with high-quality manufacturing capabilities.”

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. The $3.2 billion manufacturing site opened with a capacity of 8 x 20,000 liters (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 will accelerate the opening of its expansion by 6 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 kojoXTM 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

“The FDA’s selection of the Holly Springs site recognizes the robust quality foundation that underpins the facility and our network,” said Maja Pedersen, chief operating officer, FUJIFILM Biotechnologies.