The U.S. Food and Drug Administration has selected Kyowa Kirin's Sanford manufacturing facility for the FDA PreCheck Pilot Program. The program enables early-stage regulatory engagement during the construction of the state-of-the-art biologics facility in Sanford, North Carolina, which broke ground in late 2024 and is expected to be operational by 2027. It is designed to optimize current Good Manufacturing Practices compliance and validation, accelerate commercial production timelines, and strengthen supply chain resilience for rare disease patients. Kyowa Kirin's Chief Supply Chain Officer Toshiyuki Kurata called the selection a transformative milestone, noting the facility is the company's first manufacturing footprint in the U.S. The PreCheck Program replaces sequential reviews with a proactive two-phase framework, including a facility readiness phase using a Type V Drug Master File for real-time FDA feedback and an application submission phase with structured pre-submission engagements to streamline Chemistry, Manufacturing, and Controls reviews.
Kyowa Kirin Co., Ltd.FDA selected Kyowa Kirin's facility for PreCheck Pilot Program, accelerating manufacturing timelines and regulatory engagement
Commercial Metals Company