Cellares turns from R&D to commercialization with automated cell therapy manufacturing
San Francisco-headquartered Cellares, which describes itself as an integrated development and manufacturing organization (IDMO), continues to make progress in its quest to transform the way cell therapies are manufactured at commercial scale.
Cellares is deploying its Cell Shuttle, which automates cell therapy manufacturing, and Cell Q, which automates quality control, at the company’s IDMO “smart” factories. The first commercial scale smart factory is operational in Bridgewater, New Jersey, with other facilities under construction in Europe and Japan.
“If I had to summarize 2024, we really turned the page from R&D to commercialization,” Fabian Gerlinghaus, co-founder and CEO of Cellares, told Pharma Manufacturing. “We now have commercial-ready, cGMP-compliant versions of the Cell Shuttle and the Cell Q for automated manufacturing and quality control.”
Gerlinghaus said Cellares has “signed up” five large pharma companies as customers — two of which, Bristol Myers Squibb (BMS) and Gilead’s Kite, have been publicly disclosed — as well as smaller biotechnology companies such as Caballeta Bio and Lyell Immunopharma.
For smaller biotechs, Gerlinghaus claims its technologies can help them reach the Investigational New Drug (IND) application stage in about eight months, rather than 16 months. “We can cut down the time that it takes them from get-go into the clinic by about 50%,” he said. “We do that by offering a standardized CAR T cell therapy process.”
On the Big Pharma side, Cellares in April 2024 announced a worldwide capacity reservation and supply agreement with BMS — worth up to $380 million — which will utilize its proprietary Cell Shuttle platform for the clinical and commercial-scale manufacturing of select CAR T cell therapies. In June 2024, the company announced that Kite is evaluating Cell Shuttle to determine the viability of the automated, high throughput manufacturing platform.
“We’ve delivered data to all of these customers demonstrating we can run their processes successfully,” according to Gerlinghaus. “We’ve done a number of end-to-end runs demonstrating to our customers that we can run their processes and meet spec.”
Eliminating bottlenecks
When it comes manufacturing CAR T cell therapies, Gerlinghaus contends that the industry is “held back” by bottlenecks — the root cause of which are manual processes that are “unscalable, error prone, and expensive.” As a result, he said patients on wait lists for these therapies are dying despite FDA-approved cell therapies on the market.
Gerlinghaus claims Cellares can deliver to its customers “10 times the scale” of manufacturing at “half the price” of current manual processes, which he described as “artisanal” requiring teams of scientists using a “plethora of disjointed benchtop equipment” for one patient at a time.
Cellares’ Cell Shuttle simultaneously handles 16 cartridges — which means therapies for 16 patients — and automates the entire process, according to Gerlinghaus, who adds that to his knowledge the company is also the only one that has attempted to automate quality control and release testing for cell therapies.
“Our technologies reduce the number of employees and facilities space required by about 90% to produce the same amount of cell therapy doses, or put differently — with the same resources, the same number of employees and facilities space, we could produce 10 times more cell therapies,” Gerlinghaus said.
The bottom line, according to Gerlinghaus: “It is cheaper for a pharma company to outsource CAR T cell manufacturing to Cellares than it is for them to manufacture in-house.”
Global expansion, raising funds
Cellares’ first U.S. commercial scale site is operational in Bridgewater, New Jersey, which will be capable of producing up to 40,000 standard CAR-T cell therapy doses annually, or up to 100,000 doses of novel, two-day process CAR-T cell therapies.
To fulfill contractual agreements with customers, the company has “dramatically accelerated” its global expansion and is building new sites in Belgium and Japan, which Gerlinghaus said will reach commercial scale manufacturing in about two years or so.
The Bridgewater facility has the capacity to accommodate 38 Cell Shuttles, while the sites in Europe and Japan will each house 48 Cell Shuttles. When all three facilities are up and running, Cellares estimates that it will produce up to 380,000 patient doses per year.
“What’s ahead for us in 2025? Execution, execution, execution,” Gerlinghaus declared. “We’re not slowing down. We’re continuing to hire world-class talent and chasing aggressive timelines, as we have been doing for the last six years.”
The company currently has about 250 employees and last year added several key C-suite positions including Chief Operating Officer Ossama Eissa, a former executive at Legend Biotech, Lonza Biologics, and Novartis.
Eissa was a general manager who led commercial-scale sites for two of the six FDA approved CAR-Ts on the market as of 2023, Carvykti at Legend Biotech and Kymriah at Novartis, according to Gerlinghaus.
“The Venn diagram of people who’ve got that level of experience and live within commuting distance of Bridgewater [New Jersey] is exactly one person — that’s Ossama and we hired him,” he said.
In August 2023, Cellares secured $255 million in Series C funding led by new investor Koch Disruptive Technologies with participation from BMS, bringing the total raised at that time by the company to more than $355 million. Now, Gerlinghaus says Cellares is looking to add to its financing with $250 million in Series D funding.
“We’re actually right now in the Series D financing process,” he said, noting that the company will be completing the fundraising soon.
