After almost five years, Cellares has completed the build of its first clinically ready Cell Shuttle, a cell therapy manufacturing platform designed to meet global patient demand while reducing costs and process failure rates. Building the Current Good Manufacturing Practice (cGMP)-compliant Cell Shuttle is an essential milestone in ensuring clinical readiness.
“In a nutshell, the news is that we’ve got the first Cell Shuttle that will be used to make the first drugs that go into humans,” Cellares co-founder and CEO Fabian Gerlinghaus told GEN Edge. “We’ve built the plane, and now we’re going to fly it.”
Cell Shuttle v2
The initial Cell Shuttle was a proof of concept for executing fully automated self-manufacturing workflows. However, this initial model couldn’t have been used to make drugs that go into humans because it wasn’t cGMP-compliant.
The ultra-high-throughput, automated Cell Shuttle takes in cells and then goes through several automated steps to manufacture a formulated cell therapy product ready for clinical use. The cell therapy manufacturing platform initially planned to incorporate freezing the product. Still, Gerlinghaus said that every customer has a different requirement concerning the type of plastic bag. Instead, Cellares will manually fill and freeze the products according to the customer.
The number of annual doses the Cell Shuttle produces depends on the length of the cell therapy manufacturing process. If the process takes two days, like T-charge, the CAR T platform from Novartis, the Cell Shuttle can produce up to 2,800 cell therapies annually. But if the process takes 14 days, seven times longer, the production is cut down to around 400 cell therapies per year.
Gerlinghaus said that Cellares goes through the design-build-test cycle roughly every year and a half, and this Cell Shuttle is the result of the completion of that final development cycle that enables them to make drugs that go on to humans.
Supporting commercial-scale engagement
Since August 2023, when Cellares rolled out five announcements in one week—including a $255 million Series C and investment from Bristol Myers Squibb—Gerlinghaus has said that an “avalanche of business interests” have been coming their way. Since then, Cellares has inked eight commercial agreements and will announce a major corporate partner later in 2024, but Gerlinghaus declined to name particular customers.
“We will support clinical trials for many different biotech and pharma companies over the next few years,” said Gerlinghaus. “We’re building dozens of Cell Shuttles in 2025 and 2026 to support the first commercial-scale engagement.”
Cellares is not selling the Cell Shuttle to third parties. According to Gerlinghaus, by the end of this year, Cellares will deploy five CGMP Cell Shuttles in its Integrated Development and Manufacturing Organization (IDMO) smart factories—three in Bridgewater, NJ, and two in South San Francisco—that will provide thousands of clinically ready doses for infusion into humans.
Dozens of Cell Shuttles, Thousands of doses
Gerlinghaus said that over the next few years, Cellares intends to make dozens of Cell Shuttles for its growing number of IDMO smart factories. To become a global distributor of cell therapies, Cellares will break ground on another European facility, specifically Belgium, and then expand to Japan.
“We’re excited about the mission that we’re on, which is to ultimately meet the total patient demand for cell therapies globally while also standardizing cell therapy manufacturing,” said Gerlinghaus. “We’re enabling unprecedented scale and capacity because of the super high throughput and the automation. We’re reducing the cost by up to 50% per batch processed. Failure rates go down by up to 75%—that’s unheard of, and that’s exactly what the industry needs. Because of that, I’m very confident that, five years from now, Cellares will be the de facto standard for cell therapy manufacturing.”
