Cellares is the first cell therapy platform accepted to FDA's Inaugural Manufacturing PreCheck Cohort
Cellares announced its acceptance into the U.S. Food and Drug Administration's inaugural Manufacturing PreCheck Pilot Program, giving Cellares early and ongoing engagement with the FDA as it advances its cell therapy manufacturing network toward commercial-scale production.
The FDA Manufacturing PreCheck Program is a voluntary pilot initiative authorized under Executive Order 14293, designed to allow domestic pharmaceutical and biologic manufacturers to engage with the FDA early, before a product application is filed. Participation provides access to facility-specific Drug Master File (DMF) reviews, Pre-Operational Reviews, Pre-Submission Evaluations of GMP Facilities, and structured dialogue covering facility design, quality systems, and manufacturing processes. The program was created to strengthen the domestic pharmaceutical supply chain by ensuring new manufacturing facilities are built in alignment with regulatory expectations from the outset. The FDA received over 80 requests to participate, selecting just seven companies for the inaugural cohort.
For Cellares, PreCheck selection means direct, ongoing FDA engagement and collaboration as the company advances its network of GMP IDMO Smart Factories toward commercial-scale production. The structured pre-operational review process allows Cellares to validate its Cell Shuttle manufacturing and Cell Q quality control systems against FDA standards before product applications are filed, compressing regulatory timelines and reducing risk for drug sponsors who develop and commercialize therapies on Cellares’ platform. For sponsors, that means reduced CMC risk at BLA, a shorter path to commercial readiness, and a manufacturing partner whose facility has been validated through the PreCheck process and maintains a transparent relationship with the FDA.
