Automated U.S.-based cell therapy manufacturing advances national security, health resilience, and domestic industrial capacity

South San Francisco, CA — June 10, 2026 — Cellares, the world’s first Integrated Development and Manufacturing Organization (IDMO) dedicated to automated cell therapy production, announced today it has joined the New American Industrial Alliance (NAIA), a coalition committed to rebuilding America’s strategic industrial base and restoring domestic manufacturing leadership.

Cellares joins NAIA as part of its mission to help establish a resilient, sovereign U.S. biomanufacturing ecosystem capable of producing next-generation medicines at scale while reducing dependence on foreign manufacturing infrastructure.

NAIA is a multi-sector trade association dedicated to ensuring America is the techno-industrial leader of the world, uniting builders, investors, and policymakers committed to restoring domestic manufacturing capacity, bolstering national security, and ushering in a new era of economic prosperity. The organization convenes over 1,000 decision-makers representing more than $1 trillion in investable capital, with members drawn from defense, aerospace, advanced manufacturing, energy, and venture capital.

As geopolitical competition intensifies and supply chain vulnerabilities become increasingly acute and dangerous, America’s dependence on overseas pharmaceutical manufacturing represents a growing strategic and national security risk. Today, the vast majority of biologic medicines consumed in the United States are manufactured abroad, leaving critical U.S. healthcare infrastructure exposed to supply disruptions, geopolitical instability, and foreign industrial policies designed to undercut domestic production.

Cellares is building a concrete alternative. With operational Smart Factories in South San Francisco and Bridgewater, New Jersey — and additional facilities in Europe and Japan — the company is establishing a globally distributed but U.S.-anchored manufacturing network of advanced automation to transform cell therapy manufacturing from a labor-intensive process into a scalable industrial capability. The technology reduces labor requirements by up to 80%, facility footprint by up to 90%, and enables commercial-scale production of advanced therapies previously constrained by manufacturing complexity.

Cellares currently operates Smart Factory™ facilities in South San Francisco, California and Bridgewater, New Jersey, creating high-value American manufacturing jobs while establishing domestic production capacity for one of the most strategically important sectors of the 21st-century bioeconomy. The company’s U.S. facilities are expected to support commercial cGMP operations beginning in 2027 and provide capacity for up to 50,000 patient doses annually.

“America’s leadership in biotechnology must be matched by leadership in manufacturing,” said Fabian Gerlinghaus, CEO and Co-Founder of Cellares. “Joining NAIA reflects our commitment to strengthening the nation’s strategic biomanufacturing capabilities and ensuring that life-saving therapies invented in America can also be manufactured in America. Automated biomanufacturing is more than only a healthcare imperative; it is a matter of economic security, supply chain resilience, and national competitiveness.”

Cellares has demonstrated significant momentum in advancing U.S. biomanufacturing infrastructure. The company has successfully manufactured GMP cell therapy products that have been infused into patients, secured a $380 million worldwide capacity reservation and supply agreement with Bristol Myers Squibb, raised more than $600 million in private capital, and received the FDA’s first-ever Advanced Manufacturing Technology (AMT) designation—recognition of the transformative potential of its manufacturing platform.

As policymakers increasingly prioritize domestic production of critical technologies and strategic supply chains, Cellares represents a new model for American industrial leadership—combining biotechnology innovation, advanced manufacturing, automation, and software-driven production to create resilient domestic capacity.

By establishing scalable, cost-competitive manufacturing infrastructure within the United States, Cellares is helping build the foundation for a stronger national biomanufacturing ecosystem—one capable of supporting public health preparedness, strengthening economic competitiveness, and ensuring America remains the global leader in the development and production of advanced medicines.

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.

Cellares Contacts

Business Development: bd@cellares.com

Investors: ir@cellares.com

Media: pr@cellares.com