Cellares Accepted to FDA's Inaugural Manufacturing PreCheck Cohort, the Only Cell Therapy Platform Among Seven Companies Nationwide

The pilot gives Cellares direct, ongoing engagement with the FDA during facility development and application submission periods, compressing regulatory timelines and de-risking the path to commercial-scale production for the drug sponsors building on Cellares’ platform.

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Cellares, the first Integrated Development and Manufacturing Organization (IDMO), today 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.

The program reflects the Trump administration’s commitment to reducing U.S. dependence on foreign pharmaceutical manufacturing. In announcing the cohort, HHS Secretary Robert F. Kennedy Jr. said the PreCheck program will help bring pharmaceutical manufacturing back to the United States and strengthen the nation’s drug supply chains. With the majority of biologic medicines used in the United States still manufactured overseas, Cellares is building automated, domestic capacity purpose-built to advance the onshoring of cell therapy production.

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.

"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."

The PreCheck selection adds to Cellares’ growing body of regulatory recognition. The Cell Shuttle is the first cell therapy manufacturing platform to receive the FDA’s Advanced Manufacturing Technology (AMT) designation, and Cellares has achieved FDA clearance of an IND Amendment enabling active clinical manufacturing on the Cell Shuttle. Together, these milestones position Cellares as the only automated cell therapy manufacturing platform to hold both AMT designation and PreCheck program membership, establishing Cellares as the regulatory benchmark for automated cell therapy manufacturing in the United States.

About Cellares

Cellares is the first Integrated Development and Manufacturing Organization (IDMO), providing global cell therapy development and manufacturing services through an Industry 4.0 approach to the mass manufacture of the living drugs of the 21st century. The company enables drug sponsors to develop, scale, and commercialize cell therapies with the capacity, reliability, and economics required to meet total patient demand.

Cellares' fully automated platforms — Cell Shuttle® for end-to-end cell therapy manufacturing and Cell Q™ for automated in-process and release quality control — are deployed across its network of IDMO Smart Factories worldwide. These technologies deliver industry-leading manufacturing economics, higher process success rates, and the ability to produce up to 10× more cell therapy batches than conventional CDMOs with comparable footprint and headcount, resulting in the lowest cost of manufacturing in the industry. The Cell Shuttle is the first cell therapy manufacturing platform to receive the FDA's Advanced Manufacturing Technology (AMT) designation, and has demonstrated a 100% automation success rate across more than a dozen automated processes.

Cellares has achieved key clinical validation milestones, including a successful IND Amendment enabling active clinical manufacturing on the Cell Shuttle platform, and the successful dosing of first patients in a partner clinical trial, marking the platform's transition from development-stage technology to clinically validated manufacturing infrastructure. These milestones span multiple therapeutic areas and cell therapy modalities, including both oncology and autoimmune indications.

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. Through its global manufacturing network, Cellares is purpose-built to support both clinical and commercial programs and to expand access to life-saving cell therapies worldwide. For more information, visit www.cellares.com and follow Cellares on LinkedIn.