Cellares Joins New American Industrial Alliance, Advancing U.S. Biopharmaceutical Manufacturing Independence
The automated CDMO is hoping to reduce America's reliance on foreign biomanufacturing for advanced therapies.
Key Points
- Cellares has joined the New American Industrial Alliance, a coalition focused on rebuilding U.S. industrial and manufacturing capacity.
- Cellares is building on recent manufacturing milestones, including automated GMP-produced cell therapies infused into patients, an FDA Advanced Manufacturing Technology designation, and a $380 million agreement with Bristol Myers Squibb.
America is well aware of its fragile supply chain, which relies heavily on foreign manufacturing. However, COVID was a wake-up call for most when we learned just how dependent we are on countries like China and India for our medicine, too. For instance, we learned that China has near-total control of our Penicillin production.
These issues often don’t come to light until it’s too late… and I think Benjamin Franklin was right, yet again: “An ounce of prevention is worth a pound of cure.”
Cellares, a CDMO focused on the automated production of advanced therapies, hopes to do just that. They recently joined the New American Industrial Alliance, a trade group focused on restoring domestic manufacturing capacity across sectors including advanced manufacturing, energy, aerospace, defense, and venture capital.
Cellares is positioning automated manufacturing as part of a broader push for greater domestic control over the production of advanced medicines, particularly as supply chain and geopolitical risks continue to shape healthcare manufacturing strategy.
According to the company, its Smart Factory model is designed to shift cell therapy production away from labor-intensive workflows and toward more scalable automated operations. Cellares says the platform can reduce labor requirements by up to 80% and facility footprint by up to 90%.
U.S. footprint and recent milestones
Cellares operates Smart Factory facilities in South San Francisco, California, and Bridgewater, New Jersey. Those sites are expected to support commercial cGMP operations in 2027 and provide capacity for up to 50,000 patient doses/year.
Cellares has had several exciting milestones:
- First automated dose of Cabaletta Bio’s GMP CAR T therapy was infused into Lupus patients just last month
- A $380 million worldwide capacity reservation and supply agreement with Bristol Myers Squibb
- More than $600 million raised in private capital
- The FDA’s first Advanced Manufacturing Technology designation for its manufacturing platform
“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.”
Platform and operational model
Cellares describes itself as an Integrated Development and Manufacturing Organization focused on automated cell therapy production. Its platform includes Cell Shuttle for end-to-end manufacturing and Cell Q for automated in-process and release quality control.
Here’s a quick video of their automated production in action:
https://www.youtube.com/watch?v=YFnkYun5AF8
Beyond its U.S. sites, Cellares is also building facilities in Europe and Japan. The company says this network is meant to support globally distributed manufacturing while keeping a strong domestic production base in the United States.
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