Fujifilm Holly Springs Selected for FDA PreCheck Pilot

Fujifilm Biotechnologies’ 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, 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 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.

“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.”

An expansion is underway at the site 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.

More Fujifilm Insights

Contract Pharma recently met with Toshi Iida, Board Director, General Manager, Life Sciences Headquarters, FUJIFILM Corporation & Chairman, FUJIFILM Biotechnologies, at BIO 2026 where he discussed the company’s recent investments and shared his perspectives on supply chain resilience, dual sourcing, onshoring and more. Read the article.