FUJIFILM Biotechnologies Selected in FDA PreCheck Pilot Program to Advance U.S. Drug Manufacturing

As demand for U.S. manufacturing increases, Fujifilm to accelerate its expansion at the Holly Springs site by 6 months

HOLLY SPRINGS, N.C.--(BUSINESS WIRE)--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 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.

“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.

About FUJIFILM Biotechnologies

FUJIFILM Biotechnologies, made up of several legal subsidiaries of FUJIFILM Corporation, is a world-leading contract development and manufacturing organization (CDMO) for biologics, vaccines and advanced therapies. With over 30 years of experience, the Company specializes in developing and manufacturing biopharmaceuticals using microbial, mammalian, and host/virus systems. With over 5,000 employees, FUJIFILM Biotechnologies operates a fully integrated, kojoX^TM global network with major facilities in the United States, the United Kingdom, and Denmark. The Company’s kojoX operating system harmonizes processes, procedures, systems, data, facility designs and equipment across its global manufacturing network to increase speed, while ensuring consistency, quality, scalability, and supply chain resilience. FUJIFILM Biotechnologies offers comprehensive services, ranging from proprietary cell line development, to process and analytical development, and through to clinical and commercial manufacturing. For more information, go to: fujifilmbiotechnologies.fujifilm.com.

About FUJIFILM Holdings Corporation

FUJIFILM Corporation is a subsidiary of FUJIFILM Holdings Corporation. FUJIFILM Holdings Corporation, headquartered in Tokyo, leverages its depth of knowledge and proprietary core technologies to deliver innovative products and services across the globe through the four key business segments of healthcare, electronics, business innovation, and imaging with over 70,000 employees. Guided and united by our Group Purpose of “giving our world more smiles,” we address social challenges and create a positive impact on society through our products, services, and business operations. Under its medium-term management plan, VISION2030, which ends in FY2030, we aspire to continue our evolution into a company that creates value and smiles for various stakeholders as a collection of global leading businesses and achieve a global revenue of 4 trillion yen (29 billion USD at an exchange rate of 140 JPY/USD). For more information, please visit: www.fujifilmholdings.com.