With a third collaborator in tow, Cellares has all the expertise it needs to turn its focus from scouting out industry partners to tweaking and improving its forthcoming cell therapy factory in a box.
The company on Wednesday welcomed cell and gene specialist Poseida Therapeutics as the final partner in its Cell Shuttle early access partnership program. Poseida follows in the footsteps of PACT Pharma and the Fred Hutchinson Cancer Research Center, which recently teamed up with Cellares to catch a sneak peak at the Cell Shuttle and help fine-tune the platform before its expected market debut in 2023.
Worldwide, hundreds of companies are developing new cell therapies, and scientists are underway with nearly 700 trials, Fabian Gerlinghaus, co-founder and CEO of Cellares, said in an interview. But even as that wave of potential new cell therapy drugs nears, current manufacturing approaches remain largely stuck in the past, he said.
"All of the commercially available cell therapies that are FDA-approved today are being manufactured with point solutions that are taking care of one cell therapy manufacturing unit, one patient at a time," Gerlinghaus said.
Those processes are slow, pricey and error-prone, Gerlinghaus added. The existing manufacturing approach "does not scale, and the problem is huge," the CEO said.
Get aboard the cell shuttle
Enter Cell Shuttle, Cellares' cell therapy factory in a box, which the company touts for its potential to slash process failure rates "threefold" and produce 10 or more patient doses in parallel. That's "an order of magnitude" better than existing options, the CEO said.
Roughly as big as a "truck or a decent-sized conference room," the Cell Shuttle is closed and automated, which should make it easier for companies to scale out their operations and avoid user error and contamination, he added.
Another reason that automation is key? There simply "aren't enough humans" in the highly specialized field, Gerlinghaus said.
The Cell Shuttle maintains its own cleanroom environment, which "no human ever enters." Inside the space, a robot "basically moves the single-use cartridge from one modular bioprocessing instrument to the next" to carry out the workflow, he said.
Teamwork makes the cell (and gene) work
By taking part in the Cell Shuttle early access program, Poseida, like Cellares' other partners, gets a "free look under the hood," Gerlinghaus said. In turn, Cellares receives feedback on its equipment, allowing the company to improve the process.
For the early access program, Cellares specifically sought input from a range of companies "representing different cell therapy modalities, both autologous and allogeneic," he added.
Poseida has two autologous CAR-T prospects in the clinic for metastatic castration-resistant prostate cancer and relapsed or refractory multiple myeloma. It's also developing off-the-shelf versions of both therapies, Cellares said in a release. Beyond CAR-Ts, Poseida is looking into other modalities such as T-cell receptor therapies, induced pluripotent stem cells, natural killer cell therapies and more.
The company will be on deck to evaluate Cell Shuttle prototypes and offer data and feedback on the platform's performance, Cellares said.
Part of the work will involve Cellares sitting its partners down in front of its process design studio, which lets the companies take control of their Cell Shuttle manufacturing module.
In cell therapy manufacturing, "the process is the product," Gerlinghaus said. Cellares' software lets manufacturers "define the process that defines their product."
"You don't have control over the starting material that you collect from a healthy donor or from the patient," he said. "The only thing that's under your control is what do you do to the cells from the time you collect them until you re-infuse them into the patient."
While Cellares is certainly optimistic about its Cell Shuttle offering, it remains to be seen how widely it'll be used across the industry. The top cell therapy players have already invested heavily in production, so they'll need to be convinced before abandoning their existing processes. Still, Gerlinghaus says the buzz from its early partners is promising.
The company can't get into specifics right now, but some of those collaborators, like PACT, are already "stepping up their commitment," and so far, feedback on the Cell Shuttle has been "phenomenal," he said. With the program wrapping up soon, Cellares' next mark will be bigger, "more forward-looking" partnerships, Gerlinghaus said.
Editor's note: This story was updated to clarify that Cellares' early access program is effectively wrapping up and not recruiting any new partners, but there are still ongoing discussions that might result in another addition to the program.