After speedrunning a series of major manufacturing milestones in the past year and a half, the “biotech floodgates” have opened for Cellares, the automated cell therapy manufacturing specialist’s co-founder and CEO told Fierce Pharma Manufacturing.
Cellares, which pitches itself as an integrated development and manufacturing organization (IDMO), has already attracted interest from cell therapy majors like Bristol Myers Squibb and Gilead Sciences’ Kite Pharma unit thanks to its automated manufacturing platform, dubbed the Cell Shuttle, and its companion automation tech for quality control, the Cell Q.
But things reached a tipping point for the company in April, when “the first cell therapies were infused into patients that were made by Cellares on our own technology—the Cell Shuttle technology—in our own facilities for a paying customer in an FDA-regulated environment,” Cellares helmsman Fabian Gerlinghaus said in a recent interview.
Cellares and its partner Cabaletta Bio revealed earlier this year that they had dosed the first two patients using rese-cel (resecabtagene autoleucel) drug product made via a trip through the Cell Shuttle.
The companies subsequently unveiled a 10-year commercial supply pact for automated production of rese-cel, a Cabaletta CAR-T therapy under investigation for autoimmune diseases spanning rheumatology, neurology and dermatology. The Cabaletta tie-up marks the second commercial agreement for Cellares following its landmark $380 million pact with Bristol Myers Squibb in 2024.
That the cell therapies produced—and put through QC rigors—on Cellares’ technology can be “delivered on time and to spec” is a “huge value inflection point for us, because it proves the entire capability stack,” Gerlinghaus said.
Framed another way, Gerlinghaus explained that the accomplishment confirms that “Cellares can build and operate GMP facilities, sign up paying customers, automate their manual processes, generate comparability data that was satisfactory to the FDA, and then make actual GMP doses for patient infusion.”
Cellares built out its technology to streamline the labor-intensive cell therapy manufacturing process, and from Gerlinghaus’ perspective, the company’s paired manufacturing and quality control platforms continue to outstrip the capabilities of other automated cell therapy production approaches taking shape on the market.
In a traditional cell therapy manufacturing workflow, one drug for one patient is produced and vetted through a labor-intensive series of processes on an array of benchtop equipment, which must then be put through a “battery” of quality control assays, per Gerlinghaus.
“You’re writing on the order of 500 pages of paper-based batch reports,” he explained.
Cellares, he argues, has “replaced all of this madness with two fully integrated technologies,” pointing to the company’s Cell Shuttle for automated manufacturing and its Cell Q platform, which brings the same level of compact automation to quality control.
Meanwhile, Cellares is already reaping the rewards of its first-in-human dosing achievement, according to Gerlinghaus, who said that passing the milestone has “opened the biotech floodgates for the company.”
“We actually doubled the number of customers since the beginning of the year, and we’re set to double again before the end of the year,” he pointed out.
With the start of the week came yet another Cellares-biotech tie-up, this time coming from Sonoma Biotherapeutics. The two companies are hoping to chart a new course for the Cell Shuttle by aiming it at engineered regulatory T cell (Treg) therapy manufacturing for Sonoma’s lead asset, the phase 1 poly-refractory rheumatoid arthritis candidate SBT-77-7101.
“That first-in-human proof shifted the biotech conversation from ‘does it work,’ to ‘how fast can we sign,’” Gerlinghaus added.
Inside the Cell Shuttle
Speaking to the breadth of the platforms’ capabilities, Gerlinghaus admitted that “end-to-end is not a dictionary term,” caveating that manufacturers define it differently.
He walked through the full suite of steps carried out on the Cell Shuttle’s journey: Enrichment in a counterflow centrifuge; cell selection using a magnetic cell sorter; activation using reagents; gene editing using either viral vectors or CRISPR-Cas9 through electroporation; expansion in a bioreactor; harvesting; and finally, fill-finish and formulation.
The Cell Shuttle itself, of which Cellares will host multiple in each of its production facilities, is “roughly the size of an Amazon truck or a conference room,” by Gerlinghaus’ estimate. The CEO said the bulky frame is necessary to deliver “really high throughput.”
Cellares has automated many of the manufacturing steps into a consumable cartridge which is then loaded into the front of its Cell Shuttle for its production journey.
Gerlinghaus described the consumable cartridge as “basically a lab in a box,” adding that “you don’t just load one for one patient; you load 16.”
In turn, that makes the overall Cell Shuttle approach “16 times higher throughput than any other instrument on the market,” Gerlinghaus argued.
That ability to juggle multiple patient doses in one cartridge and run is paramount if an automated cell therapy manufacturing technology hopes to be effective in the commercial arena, Gerlinghaus added.
As for the other real estate considerations of the Cell Shuttle, the platform consists of 10 instrument bays on its right and left side, with 20 total instruments each equivalent to “about five such benchtop instruments,” Gerlinghaus suggested, alluding to the manual tools used in traditional production workflows.
He argued that it would take 10 times more room to set up the same magnitude of instruments and workspace afforded in a single Cell Shuttle.
“In order to make cell therapy manufacturing scalable, you need high throughput, compact technologies,” Gerlinghaus said. “And you’ve got to automate not just one or two of the unit operations, but the entire workflow.”
The other key facet of Cellares’ pitch to the industry is its Cell Q solution for quality control.
Aside from automation of portions of the QC process such as sample collection out of the Cell Shuttle, the “most significant” perk of the Cell Q platform, according to Gerlinghaus, is the auto-generation of electronic batch records.
“500 pages of paper-based records written by hand per patient,” Gerlinghaus said again of the burdens of traditional, manual QC workflows. “You can do that for 10 patients in the clinical trial, with a lot of pain, but you cannot scale that to 100,000 patients per year per drug,” he argued.
Racking up wins
Aside from a Cellares-produced drug making it into human patients, the company has notched up a number of other notable wins since 2025, beginning with a major accomplishment last April when its Cell Shuttle received the FDA’s first advanced manufacturing technology (AMT) designation.
The distinction, which has been set aside for manufacturers or technology developers bringing substantial changes to the drug production process, is expected to smooth future regulatory interactions between the FDA and drugmakers who elect to take their manufacturing voyages on Cellares’ Cell Shuttle.
Meanwhile, the company kicked off 2026 by telegraphing plans to expand with new facilities in the Netherlands and Japan, and it announced the initial close of a $257 million series D fundraising round before the end of January that has since gone on to reach some $327 million in extensions.
In a further validation of Cellares’ approach, the company was recently selected as one of seven companies tapped in June for the FDA’s PreCheck Pilot program, designed to strengthen drug manufacturing and bolster U.S. supply chain resilience.
Echoing comments earlier this year from gene therapy CDMO Forge Biologics’ regulatory chief, Gerlinghaus noted that “what was so compelling for us about the PreCheck program is that it fundamentally changes when the FDA and drug manufacturers engage.”
Under the FDA’s traditional way of working, manufacturing and facility readiness comes up late in the review process for potential drug approvals, potentially leading to unpleasant surprises just as companies and their production partners are approaching the finish line.
“PreCheck moves these conversations forward by many months,” Gerlinghaus explained.
The program is broadly broken down into two phases, the first of which focuses on facility readiness and involves earlier interaction between manufacturers and the FDA for technical advice before their plants come online. In the second application submission phase, the FDA will take advantage of pre-submission meetings and inspections to help streamline manufacturing assessments and, hopefully, prevent them from scuttling approval applications at the 11th hour.
Pulling facility conversations with the FDA forward has the potential to be a “big boon for patients,” Gerlinghaus explained, “because it doesn’t delay commencement of commercial-scale manufacturing.”