South San Francisco, Calif. — Cellares has been selected for the U.S. Food and Drug Administration’s inaugural Manufacturing PreCheck Pilot Program, becoming the only cell therapy platform among seven companies chosen nationwide.
The program will give Cellares early and ongoing engagement with the FDA as the company develops its cell therapy manufacturing network for commercial-scale production.
The voluntary pilot allows domestic pharmaceutical and biologic manufacturers to work with the FDA before submitting a product application. Participants receive access to facility-specific Drug Master File reviews, pre-operational reviews, evaluations of manufacturing facilities and discussions covering facility design, quality systems and manufacturing processes.
The FDA selected seven companies for the initial cohort from more than 80 applicants.
Cellares said its participation will allow the company to evaluate its Cell Shuttle manufacturing platform and Cell Q quality-control systems against FDA standards before product applications are filed. The company expects the process to reduce manufacturing and regulatory risks for drug developers using its platform.
The program is intended to strengthen domestic pharmaceutical manufacturing and reduce U.S. reliance on overseas production.
Cellares is developing a network of automated Good Manufacturing Practice facilities, which it calls IDMO Smart Factories, to support the production of cell therapies.
“Manufacturing and facility risks are usually the ones no one considers 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 commercializing on Cellares’ platform, it means manufacturing is the one thing that won’t stand between their therapy and regulatory approval.”
Cellares said the Cell Shuttle was the first cell therapy manufacturing platform to receive the FDA’s Advanced Manufacturing Technology designation. The company has also received FDA clearance of an Investigational New Drug application amendment permitting clinical manufacturing on the platform.
The company said it is the only automated cell therapy manufacturing platform to hold both the Advanced Manufacturing Technology designation and membership in the PreCheck program.
