Cellares has announced its acceptance into the US 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 that enables domestic pharmaceutical and biologic manufacturers to engage with the FDA before product applications are filed.
The programme provides structured reviews of facility design, quality systems and manufacturing processes, so new facilities can align with regulatory expectations from the outset.
The FDA received more than 80 requests to participate and selected seven companies for the inaugural cohort.
For Cellares, PreCheck selection means direct FDA engagement as the company advances its network of GMP IDMO Smart Factories toward commercial-scale production.
The preoperational review process allows Cellares to validate its Cell Shuttle manufacturing and Cell Q quality control systems against FDA standards before product applications are filed, helping sponsors to reduce CMC risk, shorten the path to commercial readiness and build on a platform with transparent FDA engagement.
"Manufacturing and facility risks are usually the ones no one sees until a pre-approval inspection or a complete response letter, long after a sponsor has filed," said Eric Fulmer, Senior Vice President of Global Quality at Cellares.
"PreCheck moves that conversation up by several years, to a time before a facility is even in operation, which is taking it off the critical path. For the sponsors building and commercialising on Cellares’ platform, it means manufacturing is the one thing that won't stand between their therapy and approval."
The PreCheck selection adds to Cellares’ regulatory recognition.
The Cell Shuttle is the first cell therapy manufacturing platform to receive the FDA’s Advanced Manufacturing Technology designation, and Cellares has FDA clearance of an IND Amendment enabling active clinical manufacturing on the platform.
Together, these milestones make Cellares the only automated cell therapy manufacturing platform with both AMT designation and PreCheck program membership, reinforcing its position as a regulatory benchmark for automated cell therapy manufacturing in the United States.
