Cellares Joins Alliance Focused on U.S. Biopharmaceutical Manufacturing

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First cGMP Cell Shuttle & Cellares co-founders Omar Kurdi (left) and Fabian Gerlinghaus (right).

South San Francisco, Calif. — Cellares said it has joined the New American Industrial Alliance, a coalition focused on rebuilding America’s strategic industrial base and restoring domestic manufacturing leadership.

Cellares, an Integrated Development and Manufacturing Organization focused on automated cell therapy production, said joining the alliance supports its goal of helping build a resilient U.S. biomanufacturing ecosystem capable of producing next-generation medicines at scale.

The New American Industrial Alliance is a multi-sector trade association that brings together builders, investors and policymakers focused on domestic manufacturing capacity, national security and economic growth. Its members include companies and investors from defense, aerospace, advanced manufacturing, energy and venture capital.

Cellares said U.S. dependence on overseas pharmaceutical manufacturing has created strategic and supply chain risks, particularly as geopolitical competition and supply disruptions become more acute.

The company said it is building a U.S.-anchored manufacturing network through Smart Factory facilities in South San Francisco and Bridgewater, N.J., along with additional facilities in Europe and Japan. Cellares said its technology can reduce labor requirements by up to 80 percent and facility footprint by up to 90 percent, while enabling commercial-scale production of advanced therapies.

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.”

Gerlinghaus said automated biomanufacturing is also tied to economic security, supply chain resilience and national competitiveness.

Cellares said it has 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 Advanced Manufacturing Technology designation.

The company said its model combines biotechnology, advanced manufacturing, automation and software-driven production to create resilient domestic capacity for advanced medicines.