An automated approach to saving lives

For patients with serious ailments—ranging from cancer to autoimmune diseases—access to cell therapies can mean the difference between life and death. But since cell therapies are created for each patient individually, they’re incredibly difficult to scale. As a result, demand greatly outstrips supply, meaning thousands of people around the world can’t access these crucial treatments.



Enter Cellares, a South San Francisco–based pharmaceutical firm on a mission to accelerate access to critically important therapies. Utilizing a network of smart factories and a vertically integrated business model, the company offers a radical reimagining of how cell therapies can be made, from development to manufacturing to regulatory support. And—just as significant—it presents an easier path to scalability.



“Over the next decade, millions of patients will live that would have other-wise died, because of the work we’re doing at Cellares together with our partners,” says Cellares CEO and cofounder Fabian Gerlinghaus. That trailblazing work—and its projected impact—has earned Cellares a spot on Fast Company ’s list of the world’s Most Innovative Companies for 2024.



THE IDMO ADVANTAGE



Cellares bills itself as the world’s first “integrated development and manufacturing organization,” or IDMO. Traditional pharma firms often rely on partnerships with contract development and manufacturing organizations (CDMOs) that, in turn, provide a range of outsourced assistance, from developing drug formulations to manufacturing the end product.



The problem, as Gerlinghaus puts it, is that most CDMOs rely on third-party benchtop equipment to manufacture cell therapies. “They’re inefficient, expensive, very failure-prone, and not scalable,” he says. By contrast, Cellares’s integrated approach means the company uses its own equipment to handle every step of the development and manufacturing process. “We’ve designed, built, and tested the most scalable and cost-efficient cell therapy manufacturing platform on the planet,” Gerlinghaus adds. “That’s a tremendous innovation.”







At the heart of Cellares’s IDMO approach are its innovative Cell Shuttle platforms. These automated machines, housed in fully self-contained units about the size of a delivery van, are designed to mass-produce cell therapies. One Cell Shuttle can produce 16 different patient doses of cell therapy simultaneously—a considerable upgrade over traditional technologies that can handle only one patient dose at a time. “The Cell Shuttle,” Gerlinghaus says, “is functionally equivalent to a hundred different benchtop instruments.”



BOOSTING SCALABILITY AND EFFICIENCY



The technology also addresses several challenges encountered in current cell-therapy manufacturing. According to Gerlinghaus, Cellares’s fully automated process reduces the rate of process failures by 75% and requires 90% less labor compared with conventional platforms, leading to substantial cost savings for drug developers. The machines’ compact design takes up 90% less facility space than traditional cell therapy technologies, making them highly scalable and adaptable. Thanks to these factors, Gerlinghaus says, Cellares can produce 10 times more cell therapies with the same amount of facility space and the same number of employees, while offering up to a 50% lower price per dose, compared with conventional CDMOs.



Cellares’s solutions are on the brink of treating actual patients in clinical trials, and the company has forged partnerships with several leading pharma companies, including Bristol Myers Squibb. To meet demand for cell therapy, Cellares is bolstering the production capacity of its two U.S. smart factories, with new facilities planned for Belgium and Japan. “We’re scaling out to get global coverage,” Gerlinghaus says. “In this way, we intend on fulfilling our mission to accelerate access to lifesaving cell therapies and meet the total patient demand for cell therapies globally.”