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You can read our first interview with Fabian Gerlinghaus, from November 2024, here.
Thank you so much for joining us again. Since we last spoke, there have been so many announcements - the Cell Shuttle getting the FDA AMT designation, contracts to start building in Japan, and, of course, Bridgewater opening as the first IDMO Smart Factory. Could you give us an overview of the past year at Cellares?
Yeah, I think we've been on an exceptionally fast globalization path. We signed the $380 million partnership with Bristol Myers Squibb in April 2024. That partnership is for commercial-scale cell manufacturing in the U.S., Europe, and Japan.
We’ve been really busy executing on that and accelerating the build-out of our first commercial-scale IDMO Smart Factory in Bridgewater, New Jersey.
At the same time, we’re building new facilities in Europe, Japan, and Asia, and we’re moving into a larger headquarters in South San Francisco. We’re currently building five facilities, simultaneously, while going through all the tech transfer, automation, and regulatory work with the cell therapies that we’re running for BMS. It’s been a really full year - a lot of work!
And then, as you mentioned, we got the AMT designation. We were the first company to receive that from the FDA for a cell therapy manufacturing platform.
That’s a big endorsement - it lowers the perceived risk for customers adopting our technology. It also offers them real benefits: when they cross-reference our AMT designation in their filings, they get faster processing times. Moreover, TIME named the Cell Shuttle one of the most important inventions of 2025.
Most importantly, the way we do business is always with a stage-one agreement first - taking a manual cell therapy process, automating it, putting it on the Cell Shuttle, running multiple end-to-end rounds, and showing we can hit all the CQAs. We’ve closed out more than half a dozen of these programs. We’ve never failed to automate a customer’s manual process on the platform.
Wow, that’s a very impressive achievement and a great framing for the year. So, with Bridgewater, what concrete milestones make you feel the facility is ready to hit the ground running and scale globally?
We did the build-out in phases. Since this year, we’ve had about 40 people in the building. We already built a number of Cell Shuttles and Cell Qs while finishing construction on the last third of the building. Construction is about to finish - that’ll close out in Q1 2026.
We’ve already been inspected by the New Jersey Department of Health and received a drug manufacturing license. So, at this point, Bridgewater is officially a cGMP-compliant facility.
What’s ahead for us is supporting multiple clinical trials in 2026, before the first commercial-scale launch in 2027.
Could you give me a sense of scale? So, with the Bridgewater factory in New Jersey - is that enough for all of New Jersey, New York, Maine?
I would say it’s helpful to think about it in terms of patient demand for an individual drug. For CAR T-cell therapies, demand ranges somewhere between 10,000 patients per year, per drug, globally, on the lower end; and up to 100,000 patients per year, per drug, on the higher end.
10,000 would be oncology CAR T. 100,000 would be autoimmune CAR T.
Broadly speaking, the patient demand split is around 50 percent in the United States, 25 percent in Europe, and 25 percent in Asia. So, if you’re just asking about the United States, that’s somewhere between 5,000 and 50,000 patients per drug, per year.
Bridgewater, alone, can produce between 20,000 and 100,000 patient doses per year.
There’s a wide range because the length of the cell therapy manufacturing process directly impacts capacity. Older processes are 10 days long. Newer ones can be as short as two days. A two-day process means you can manufacture five times as many cell therapy batches per year.
That’s why the range is so wide. But Bridgewater is a really strong start for meeting U.S. patient demand for a few drugs, at commercial scale. Europe and Japan will be structured similarly.
As you're looking at multiple sites around the world, how do you ensure consistency in product quality? Are multiple sites manufacturing the same therapies, or have you got them segmented off?
We have a huge strategic advantage here because manufacturing and quality control are automated.
Normally, for everyone else, bringing up a new facility means hiring thousands of employees and training them on super manual processes, with many manual steps.
For us, the advantage is that both manufacturing and QC are fully automated on the Cell Shuttle and the Cell Q. So, when we tech-transfer to a new site, we basically press a button to transfer the manufacturing and QC protocols. The systems will do the exact same thing at the new facility as they did in the previous one.
We only have to hire and train about 10 percent of the people we’d otherwise need. Training is much faster because they’re getting trained on automated processes, instead of manual ones.
What are the next technological goals for the Cell Shuttle as you look to improve the quality of work produced?
It really comes down to quality improvements, cost improvements, and expanding the scope of the Cell Shuttle, so it can support more niche modalities and cell types. On top of that, integrating more process analytical technologies (PAT) for online QC and process monitoring.
Speaking to people in the industry this year, especially at Jefferies, there’s a lot of interest in manufacturing automation. What would you say is Cellares’ competitive advantage?
Well, I think what really sets us apart is the degree of automation and the throughput.
Most others are building benchtop instruments with incremental improvements on the benchtop instruments that came before. They might handle two or three manufacturing steps for one patient at a time, for instance.
The Cell Shuttle handles all unit operations - the entire manufacturing process - for up to 16 patients at a time!
Moreover, to the best of my knowledge, we’re the only company that has automated quality control.
Ultimately, our factories can produce as many therapies as ten manual facilities, with only ten percent of the people and ten percent of the space. That gives us the capacity to meet patient demand, not just in the U.S., but also in Europe and Japan.
As far as costs go, there’s a lot of anxiety in biotech about capital markets. You have long-term infrastructure commitments with Smart Factories. How are you balancing your cash management?
We’ve de-risked the long-term infrastructure by securing the long-term capacity reservation and commercial supply agreement with Bristol Myers Squibb - the $380 million deal.
We also have other contracts with large pharma to further de-risk the build-out.
Autologous ex vivo cell therapies are an established asset class, with more than half a dozen drugs on the market and more than 2,000 active clinical trials. I don’t see cell therapy slowing down.
What progress are you hoping to make by the end of 2026?
By the end of 2026? Well, we’re in the final stretch of wrapping up our Series D - there’s going to be a Series D announcement soon. We’re about to reach first-in-human and support the first clinical trials for our customers. This is a huge end-to-end validation.
Cellares is six-and-a-half years old. Four-and-a-half years building the platform, two-and-a-half years commercializing and doing tech transfer. Now we’re tying it together and supporting multiple clinical trials, next year - for the first time, making therapies entirely produced by Cellares employees, in our own facilities, in our own IDMO Smart Factories, for paying customers.
In 2027, we’ll do the first commercial launch of an FDA-approved CAR-T therapy on our platform. That’ll be the fastest ramp-up of any CAR-T launched to date.
Is there anything more you can tell us about these clinical trials?
Regarding the first clinical trials, in March 2025, we shared that Cellares and Cabaletta Bio successfully completed manufacturing of Rese-cel, through the Technology Adoption Partnership, on the Cell Shuttle platform, opening the door to clinical and commercial manufacturing.
Any challenges, over the past year, that you’ve overcome that have really stood out?
Yeah, I’d say two-fold. Turning the page from R&D to operations and commercialization. Capital markets have been tough, so being in the final stretch of wrapping up Series D is a huge achievement.
Getting the BMS commercial contract - that $380 million contract - was critical. Once we signed it, my co-founder and his team got on planes to scout facilities in Europe, Japan, and Asia to deliver on our obligations.
That meant setting up legal entities, negotiating leases in multiple countries, while building five facilities at once.
In parallel, we worked with BMS on technical, scientific, and regulatory pathways. That required strong leadership.
We hired Ossama Eissa, our COO, about a year ago. He previously launched Kymriah at Novartis and Carvykti at Legend Bio and having him was profoundly important. He’s done it manually, twice, and now he’s doing it again, but, thanks to the automation, it’s given him, you know, “superpowers.”
It sounds like your priority is to make Cellares an end-to-end company. What do you see as the long-term future; in five to ten years from now?
For Cellares, the aspiration is to run biopharmaceutical manufacturing in the United States and the world - period.
That means expanding to manufacture other drug modalities beyond cell therapies.
