HOLLY SPRINGS, NC, 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…