Regeneron Among Seven Firms in FDA PreCheck Pilot for Saratoga Plant
REGN•Regeneron is among seven companies in the FDA’s PreCheck Pilot Program to expedite its Saratoga Springs biotech facility for drug substance, sterile injectables and novel proteins. The two-stage scheme grants early FDA review of facility design and QC measures, aiming to shorten approval timelines and bolster supply chain readiness.
1. FDA PreCheck Pilot Selection
Regeneron has been named one of seven companies selected for the FDA’s PreCheck Pilot Program, an initiative launched in February 2026 to expedite pharmaceutical manufacturing facility construction by assessing projects based on product pipeline, development stage and anticipated market timeline.
2. Saratoga Springs Facility Plans
The Saratoga Springs, New York site will be configured to produce biotechnology drug substance, sterile injectables and novel protein therapeutics targeting multiple disease areas, enhancing Regeneron’s domestic production capacity.
3. Program Process and Benefits
Participants enter a two-stage process: a Facility Readiness phase for early FDA feedback on design, construction and quality control, followed by an Application Submission phase focused on chemistry, manufacturing and controls to streamline approval and reduce potential delays.
