- FUJIFILM Biotechnologies has been selected as one of seven participants in the U.S. Food and Drug Administration’s (FDA) PreCheck Pilot Program at its Holly Springs, North Carolina manufacturing facility.
- The FDA initiative is designed to improve manufacturing readiness, regulatory predictability, and facility inspections to strengthen U.S. pharmaceutical manufacturing and accelerate patient access to medicines.
FUJIFILM Biotechnologies has announced that its commercial-scale cell culture manufacturing facility in Holly Springs, North Carolina, has been selected as one of seven participants in the U.S. Food and Drug Administration’s (FDA) PreCheck Pilot Program. The CDMO said the initiative is intended to strengthen U.S. pharmaceutical manufacturing capabilities by improving manufacturing readiness, regulatory predictability, and facility inspections to help accelerate patient access to critical medicines.
The Holly Springs site manufactures monoclonal antibodies (mAbs) for customers including argenx, Johnson & Johnson, Regeneron, and other pharmaceutical companies. Fujifilm said the FDA pilot program will facilitate earlier engagement between industry and regulators to reduce uncertainty associated with manufacturing readiness while supporting a more efficient regulatory review process and strengthening the resilience of the U.S. pharmaceutical supply chain.
“We are honored that our Holly Springs site has been selected to participate in the FDA’s PreCheck Pilot Program. 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.”
Lars Petersen, president and chief executive officer of FUJIFILM Biotechnologies
The Holly Springs facility, a US$3.2 billion investment, is one of North America’s largest end-to-end cell culture biopharmaceutical manufacturing facilities. It currently has a capacity of eight 20,000-liter mammalian cell culture bioreactors and is scheduled to add a drug product line in early 2027, followed by finished goods capabilities. Fujifilm is also expanding the site by adding another eight 20,000-liter bioreactors to double drug substance capacity and has accelerated the expansion timeline by six months, targeting completion in late fiscal year 2027.
The company said the facility recently exceeded 800 employees and aims to employ 1,400 people by 2031. Designed with standardized platforms and digital capabilities, the site is integrated into Fujifilm’s kojoX™ operating system to support technology transfer, manufacturing flexibility, and consistent quality across its global contract manufacturing network.
