Fujifilm’s commercial-scale cell culture manufacturing facility in Holly Springs, North Carolina, has been selected as one of only seven participants in the US Food and Drug Administration’s (FDA) PreCheck Pilot Programme. The programme is a strategic initiative designed to strengthen America’s pharmaceutical manufacturing capabilities and help accelerate patient access to critical medicines.
The pilot program enhances FDA-industry engagement by facilitating earlier interactions to minimise uncertainty associated with manufacturing readiness, designed with the hope of creating a more efficient regulatory review process, and strengthening the resilience of the US pharmaceutical supply chain. The FDA PreCheck Pilot Programme 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.
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 eight x 20,000 litres 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 eight x 20,000-litre bioreactors. With an increase in demand for US manufacturing capacity, Fujifilm 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.
