Cellares, the innovative biotechnology firm with a major commercial-scale “Smart Factory” located in Bridgewater, has been named one of only seven companies nationwide to join the U.S. Food and Drug Administration’s (FDA) inaugural Manufacturing PreCheck Pilot Program.
The selection marks a significant regulatory milestone for the company, which is the only cell therapy platform among the seven participants. The FDA initiative, authorized under Executive Order 14293, is designed to modernize domestic pharmaceutical manufacturing by facilitating early, ongoing collaboration between the agency and manufacturers before official product applications are even filed.
The PreCheck program aims to fortify the U.S. pharmaceutical supply chain and reduce dependence on overseas production—a goal echoed by HHS Secretary Robert F. Kennedy Jr. For Cellares, which operates a 118,000-square-foot facility in Bridgewater, this partnership provides a direct line to the FDA as it prepares for commercial-scale production.
“Manufacturing and facility risks are usually the ones no one considers until a pre-approval inspection… long after a sponsor has filed,” Eric Fulmer, senior vice president of Global Quality at Cellares said. “PreCheck moves that conversation up by several years… which is taking it off the critical path.”
Benefits for New Jersey and beyond
By participating in the program, Cellares gains access to:
- Pre-operational reviews: Validating manufacturing processes against FDA standards before a facility is fully operational.
- Structured dialogue: Continuous engagement on facility design and quality systems, reducing regulatory uncertainty for the drug sponsors who utilize Cellares’ automated platform.
- Streamlined commercial readiness: A faster, de-risked path to bringing life-saving cell therapies to patients.
Cellares’ inclusion in the program further cements its reputation as a regulatory benchmark in the bio-manufacturing industry. The company is already the first cell therapy platform to receive the FDA’s Advanced Manufacturing Technology (AMT) designation. By holding both the AMT designation and PreCheck membership, Cellares is positioning its Bridgewater site as a cornerstone of high-tech, automated manufacturing in New Jersey.
The company’s Bridgewater Smart Factory, which creates high-value jobs in the region, is designed to support both clinical and commercial programs, with commercial cGMP operations expected to ramp up in 2027.
Headquartered in South San Francisco, California, Cellares operates its first commercial-scale IDMO Smart Factory in Bridgewater, New Jersey, with additional facilities under construction in Europe and Japan.
