Fujifilm Biotechnologies’ Holly Springs, North Carolina, facility manufactures monoclonal antibodies (mAbs) and treatments for complex diseases. [Image courtesy of Fujifilm Biotechnologies]
The CDMO’s Holly Springs, North Carolina, facility was selected as one of seven participants in the program designed to strengthen United States pharmaceutical manufacturing capabilities and 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,” Fujifilm Biotechnologies President and CEO Lars Petersen said in a news release. “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, the release said. It was designed to create a more efficient regulatory review process and strengthen the U.S. pharmaceutical supply chain resilience.
“The PreCheck model enables FDA expertise and feedback to inform the acceleration of the facility development process from the outset, while allowing the FDA to identify potential facility issues before they result in deficiencies that could delay or prevent application approval,” the agency said on its website.
To be eligible for the program, applicants proposed a new domestic manufacturing facility that would be capable of manufacturing drug products to address market supply needs or improve patient access to therapies for unmet medical needs, the FDA said.
Fujifilm’s Holly Springs site serves Johnson & Johnson, Argenex, Regeneron and other leading pharmaceutical companies, manufacturing monoclonal antibodies (mAbs) and treatments for complex diseases.
“As our customers continue advancing innovative biologic therapies, manufacturing readiness and regulatory predictability are increasingly important,” Fujifilm Biotechnologies SVP and Holly Springs Site Head Laurie Braxton said. “”Our participation in the program reinforces our commitment to providing customers with high-quality manufacturing capabilities.”
The $3.2 billion Holly Springs manufacturing facility opened in September 2025 with a capacity of 8 x 20,000-liter (L) mammalian cell culture bioreactors. The company said it’s adding a drug product line at the facility in early 2027, followed by finished goods.
An expansion is underway to double drug substance capacity at the location with an additional 8 x 20,000 L bioreactors. Fujifilm said it will accelerate the opening of the expansion by six months due to an increase in demand for U.S. manufacturing capacity. The company is targeting late fiscal year 2027 for its expansion opening.
“The FDA’s selection of the Holly Springs site recognizes the robust quality foundation that underpins the facility and our network,” Fujifilm Biotechnologies Chief Operating Officer Maja Pedersen said.
The Holly Spring facility is designed with standardized platforms and advanced digital capabilities. It’s part of Fujifilm’s interconnected kojoX operating system that harmonizes systems, equipment and processes across its global sites to enable faster technology transfer, greater manufacturing flexibility and consistent quality for customers, the company said.
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