Episode 70: Cellares

In this episode of Petri Dish Perspectives, we explore Cellares, the biotech company trying to solve one of the biggest and least discussed challenges in cell therapy: how do you manufacture these complex, personalized medicines at commercial scale? From CAR-T to gene-edited cell therapies, the science may be advancing rapidly, but manufacturing remains labor-intensive, expensive, and difficult to scale. Cellares believes the answer is automation.

We’ll break down the origins of Cellares, the engineering philosophy behind its Cell Shuttle platform, and how the company is attempting to turn cell therapy manufacturing into something closer to an automated pharmaceutical factory. We’ll also explore its partnerships with companies including Bristol Myers Squibb and Cabaletta Bio, the massive investment behind its Smart Factory network, and why pharmaceutical companies have become increasingly interested in automating cell therapy production.

But there’s a major twist: Bristol Myers Squibb recently terminated its partnership with Cellares, raising questions about whether the Cell Shuttle is truly ready for commercial-scale manufacturing. We’ll unpack what happened, why manufacturing a clinical-stage therapy isn't necessarily the same as manufacturing a commercial product, and what this could mean for Cellares and the broader future of automated cell therapy.

Because the next breakthrough in cell therapy may not be another drug, it may be the factory that finally makes these living medicines scalable.

🎧 Listen now, stay curious, and don’t forget to subscribe for new episodes every Thursday!

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Transcript

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Hello and welcome to Petri Dish Perspectives, the podcast where we geek out about science and the companies shaping the future of healthcare. I’m your host, Manead, and I’m a PhD scientist by training, storyteller by choice. With every new episode released on Thursday, my goal is to deliver digestible pieces of information on healthcare companies under 30 mins. 

Today we're talking about a company that sits at a fascinating intersection of biotechnology, robotics, manufacturing, and medicine: Cellares. And the timing of this episode is particularly important because just yesterday, Bristol Myers Squibb terminated its partnership with Cellares, saying that Cellares' Cell Shuttle platform could not meet the requirements needed to manufacture BMS's CAR-T therapy Breyanzi at commercial scale. Consequently, Cellares is reorganizing and laying off approximately 100 employees after Bristol Myers Squibb canceled a major $380 million cell therapy manufacturing partnership. Cellares strongly disputes that characterization, saying its platform has already manufactured an FDA-regulated, GMP-compliant cell therapy that was successfully administered to patients. The disagreement has now become one of the most interesting tests of whether automated cell-therapy manufacturing is actually ready for prime time. 

And that is why I think Cellares is such an interesting company right now.

Quick disclaimer, I give full credit to the original articles cited in the references in the transcript!

Grab a coffee or tea, settle in, and let’s jump in!

What Makes Cell Therapy Manufacturing So Difficult?

Before we talk about Cellares, let's understand the problem it is trying to solve. Take CAR-T therapy, which we've discussed before on Petri Dish Perspectives. CAR-T essentially turns a patient's own immune cells into a living cancer treatment. A patient's T cells are collected through a process called apheresis and transported to a manufacturing facility. There, the cells are enriched and selected, activated, genetically modified so that they express a chimeric antigen receptor, or CAR, expanded to generate enough cells, formulated, tested, and ultimately returned to the patient.

That sounds relatively straightforward when you summarize it in one sentence. In reality, there are dozens of individual manufacturing steps, and many of them historically require significant human intervention. Cells are living biological material, so you can't necessarily treat them like a chemical compound moving through a conventional pharmaceutical manufacturing line. Their behavior can vary. The process has to be tightly controlled. And because the product is ultimately going into a patient, every step has to meet rigorous GMP requirements.

There is also an unusual logistical problem: the product is personalized. For autologous CAR-T, the manufacturing process starts with Patient A's cells and ends with Patient A's therapy. You can't accidentally mix Patient A's product with Patient B's. The manufacturing system has to maintain identity, chain of custody, sterility, quality, and consistency throughout the entire process.

This is one reason cell therapies can be so expensive and difficult to scale. The problem isn't necessarily that scientists don't know how to make them. The problem is that the manufacturing model was originally designed around relatively small numbers of patients and highly specialized facilities.

And as more cell therapies enter clinical development and commercialization, that model starts to break.

You could have a phenomenal therapy that works incredibly well in a clinical trial, but if you cannot manufacture enough doses at the right cost and get them to patients reliably, you don't really have a scalable medicine.

That is the industrial problem Cellares was founded to attack.

Founding Story

Cellares was founded in 2019 by Fabian Gerlinghaus and Omar Kurdi, and the founding story is one of the things that makes this company particularly interesting.

Gerlinghaus came from an engineering background rather than a traditional cell-biology career. He had an aerospace engineering mindset, and that shaped the way he looked at cell therapy. Instead of asking, "How can we make this biological process a little more efficient?" the question became much more fundamental: Why are we manually manufacturing personalized living medicines in the first place?

The company was essentially founded around the idea that cell therapy had moved from primarily being a scientific problem to being an engineering and manufacturing problem. In a 2024 Financial Times profile, Gerlinghaus described the challenge as one of building the infrastructure necessary to manufacture therapies that are effectively made to order for individual patients. The founders reportedly started the company with about $18 million based largely on their track record and the vision laid out in a pitch deck—an unusually ambitious proposition at the time. (Financial Times)

And investors initially thought the idea was somewhat crazy.

The company wasn't simply proposing to automate one step in the manufacturing process. Cellares wanted to integrate multiple pieces of equipment, robotics, software, cell-processing technologies, and quality-control systems into one automated manufacturing architecture.

That is a very difficult systems-engineering problem.

But the ambition was also obvious. If you could make cell therapy manufacturing behave more like an industrial process, you could theoretically improve reproducibility, reduce labor, shrink the facility footprint, and increase throughput.

And Cellares has spent the past several years trying to prove exactly that.

The Cell Shuttle: Turning a Cell Therapy Factory Into a Machine

The centerpiece of the company is the Cell Shuttle. The easiest way to think about it is as a highly automated biological manufacturing system designed to take many of the manual steps involved in cell therapy and integrate them into a closed, digitally controlled platform.

Cellares says the Cell Shuttle can automate processes including cell enrichment, cell selection, activation, transduction or transfection, expansion, and formulation. The system is designed around disposable consumables and closed processing, with the goal of reducing manual interventions and contamination risk. Cellares says a single system can process up to 16 batches concurrently, with each cartridge capable of running a different cell-therapy process. (Cellares)

And then there's Cell Q, which tackles another bottleneck: quality control.

Manufacturing a cell therapy is only half the problem. You also have to prove that what you manufactured meets specifications before it can be released to a patient. Traditional QC can involve numerous manual assays and processes, which adds time and labor.

Cellares wants to automate that as well.

The company's broader vision is therefore not simply "build a robot that makes CAR-T." It is to create an entire manufacturing architecture in which production, quality control, software, data, and regulatory processes are integrated.

The economics could theoretically be significant. Cellares has said its automated systems can provide roughly ten times the throughput of conventional manual facilities with comparable footprint and headcount, while reducing per-patient manufacturing costs. Those are company claims rather than independently established industry benchmarks, but they illustrate the scale of the company's ambition. (Cellares)

And this is where Cellares' IDMO model comes in.

Instead of selling a piece of equipment and asking every biotech company to build its own manufacturing facility, Cellares is building Smart Factories where its own systems can manufacture therapies for multiple customers.

It's essentially trying to become the infrastructure layer for cell therapy.

Big Validation: BMS, the $380 Million Deal, and the Road to Commercial Scale

And for a while, it looked like Cellares had found exactly the validation it needed.

In 2024, Bristol Myers Squibb signed a deal with Cellares worth up to $380 million to reserve commercial manufacturing capacity across the United States, Europe, and Japan. The agreement was designed around transferring selected BMS CAR-T manufacturing processes onto Cellares' Cell Shuttle platform, with dedicated Cell Shuttle and Cell Q systems planned for BMS. (Fierce Pharma)

This was enormous validation.

BMS wasn't some early-stage biotech experimenting with an unproven manufacturing platform. It was one of the world's largest pharmaceutical companies, with a major commercial CAR-T franchise.

And the commercial product at the center of the relationship was Breyanzi, BMS's CD19-directed CAR-T therapy. Breyanzi was approved by the FDA in 2021 and generated approximately $1.36 billion in sales in 2025. (Reuters)

So the logic was straightforward.

If Cellares could demonstrate that its platform could reliably manufacture a commercial CAR-T product for BMS, that would be enormously important—not only for Cellares, but for the entire automated cell-therapy manufacturing industry.

Cellares subsequently raised enormous amounts of capital. In January 2026, it announced a $257 million Series D led by BlackRock and Eclipse, bringing total capital raised to $612 million. By June, the Series D had grown to $327 million, with Prime Radiant Partners contributing another $50 million. (Cellares)

The company was explicitly positioning that capital toward commercial-scale operations and a potential 2027 IPO.

And then something remarkable happened.

In April 2026, the first two patients received Cabaletta Bio's investigational CAR-T therapy rese-cel, manufactured using the Cellares Cell Shuttle. Cellares reported that both GMP doses met release specifications, were delivered on schedule, and were infused into patients. (Cellares)

That was an important milestone.

Because now the question wasn't theoretical anymore.

A cell therapy manufactured on Cellares' automated platform had actually gone into human beings.

Then Came the BMS Breakup

Which brings us to the news that prompted this episode.

On August 25, 2026, Bristol Myers Squibb announced that it was ending its partnership with Cellares.

According to BMS, its assessment concluded that the Cell Shuttle could not meet the requirements necessary to manufacture Breyanzi at commercial scale. This is an important distinction: the issue wasn't that Cellares couldn't manufacture a cell therapy at all. The dispute is specifically about whether the platform could satisfy BMS's requirements for commercial-scale manufacturing of Breyanzi. (Reuters)

And Cellares strongly disagrees with BMS's characterization.

The company says its platform has already met FDA-regulated clinical standards and points to the GMP manufacturing and successful patient administration of Cabaletta's rese-cel as evidence that the technology works in a clinical setting. (Reuters)

Those two statements can actually coexist.

A platform can successfully manufacture clinical-stage product and still fail to meet the requirements of a particular commercial manufacturing process.

And that distinction is critical.

Clinical-scale manufacturing is not automatically commercial-scale manufacturing.

This is where I think we need to be careful.

It's very easy to look at the BMS termination and say, "Cellares failed."

But the evidence is more nuanced.

First, the BMS decision applies specifically to Breyanzi and its approved manufacturing process. It doesn't mean that the Cell Shuttle cannot manufacture any cell therapy. (Reuters)

Second, Cellares has continued to accumulate other partnerships.

In April, Cabaletta Bio signed a 10-year commercial supply agreement with Cellares for rese-cel. That agreement is intended to support thousands of batches per year if the therapy is approved. (Cellares)

Cellares has also announced collaborations with TScan Therapeutics for TSC-101, with Sonoma Biotherapeutics for an engineered Treg therapy, with Papillon Therapeutics for a Friedreich's ataxia program, and with City of Hope for a solid-tumor CAR-T program targeting glioblastoma. (Cellares)

And importantly, the company is trying to expand beyond traditional CAR-T.

Cellares has partnered with Stanford to automate manufacturing of gene-edited hematopoietic stem-cell therapies, potentially supporting programs targeting HIV and rare inherited diseases. (Cellares)

So the question becomes whether the BMS setback represents a company-specific manufacturing problem or a fundamental limitation of the Cellares model.

That's something we don't know yet.

And that's precisely why this is such an interesting story.

If Cellares can demonstrate that Cabaletta's rese-cel and other programs can move successfully through clinical and eventually commercial manufacturing, the BMS setback could ultimately be viewed as a specific process-transfer or product-fit problem.

If multiple programs begin encountering similar issues when moving toward commercial scale, then the thesis becomes much more concerning.

The next year or two should tell us a lot.

Competition: Cellares Isn't Alone in Trying to Industrialize Cell Therapy

Of course, Cellares isn't the only company that recognizes this opportunity.

The automated cell-therapy manufacturing ecosystem has attracted significant investment, with Ori Biotech emerging as one of Cellares' most visible competitors. Other approaches include companies such as Lonza and Miltenyi offering more distributed or instrument-based manufacturing systems, while some developers continue to build their own internal manufacturing capabilities or rely on traditional CDMOs. (Fierce Pharma)

Cellares is betting on the centralized, networked model.

The company has built Smart Factories in South San Francisco and Bridgewater, New Jersey, with facilities under development in Leiden in the Netherlands and Kashiwa in Japan. The idea is to create a globally distributed manufacturing network where the same underlying technology and processes can be replicated across regions. (Cellares)

That creates another potential advantage: technology transfer.

If you can standardize the manufacturing process digitally, theoretically you don't have to reinvent the manufacturing process every time you open a new facility.

You transfer the process.

You validate it.

And you reproduce it.

That's the dream.

But once again, the BMS situation demonstrates how difficult that dream is to execute.

Regulatory Piece—and Why the FDA's Reaction Matters

In June 2026, the FDA selected Cellares as one of seven companies nationwide for its inaugural Manufacturing PreCheck Pilot Program. Cellares was the only cell-therapy manufacturing platform selected. The program is designed to allow manufacturers to engage with the FDA earlier in facility development and regulatory planning rather than waiting until a product application is filed. (Cellares)

That came on top of the FDA's earlier Advanced Manufacturing Technology designation for the Cell Shuttle in 2025. Cellares was the first cell-therapy manufacturing platform to receive that designation. (Cellares)

Those are meaningful regulatory signals.

But they're not the same thing as the FDA saying, "This platform is ready to manufacture every commercial cell therapy."

And that's another distinction worth emphasizing.

Regulatory recognition of a manufacturing technology is not equivalent to regulatory validation of every implementation of that technology.

Every cell therapy has its own manufacturing process, its own critical quality attributes, and its own regulatory requirements.

So the real test for Cellares is not whether the Cell Shuttle can perform the underlying biological steps.

It's whether Cellares can transfer diverse manufacturing processes onto the platform and consistently produce commercial product that meets every sponsor and regulatory requirement.

That's the much harder challenge.

What's Next for Cellares?

So what happens next?

First, watch Cabaletta Bio very closely. The company has a 10-year commercial supply agreement with Cellares for rese-cel, and Cellares already manufactured the first two patient doses that were administered in Cabaletta's clinical trial. If that program continues successfully, it becomes one of the strongest pieces of evidence supporting the Cellares thesis. (Cellares)

Second, watch the other programs coming onto the platform. TScan, Sonoma, City of Hope, Stanford, Papillon, Autolus, and others are all exploring different applications of Cellares' manufacturing technology. The broader the modality mix, the more evidence Cellares can generate that its platform isn't dependent on one particular CAR-T process. (Cellares)

Third, watch the Smart Factory network. Cellares has been building facilities across the United States, Europe, and Japan, with commercial-scale operations planned for 2027. The more difficult question now is whether the company should continue aggressively building that capacity or pace the expansion until customer demand and manufacturing performance are more certain. (Cellares)

And finally, watch the IPO.

The company has raised more than $600 million privately and has discussed a 2027 public-market path. But investors are going to want evidence that Cellares has moved beyond the "great technology story" phase and into the "repeatable commercial manufacturing business" phase. (Cellares)

Closing: The Real Bottleneck in Cell Therapy Might Not Be Biology

And that brings us to the bigger question.

We've spent the last decade talking about the incredible promise of cell therapy. We've watched CAR-T turn previously devastating blood cancers into diseases where some patients can experience durable remission. We're now seeing companies explore CAR-T for autoimmune diseases, solid tumors, genetic diseases, and other conditions.

But there's a danger in focusing only on the biology.

Because a therapy isn't truly transformative if you can't manufacture it for the people who need it.

That may ultimately be Cellares' biggest opportunity.

The company is betting that the next frontier of cell therapy isn't another target or another CAR construct.

It's industrialization.

Can we take something that currently looks like a bespoke biological procedure and turn it into a standardized manufacturing process? Can we automate the steps? Can we reduce human error? Can we produce thousands of batches instead of hundreds? Can we reduce cost? Can we make the supply chain predictable? Can we transfer the same process across manufacturing sites around the world?

If the answer is yes, Cellares could become incredibly important to the cell-therapy industry.

But the BMS breakup is a reminder that industrialization is not a PowerPoint slide.

It has to work.

It has to work every time.

And it has to work at the scale, cost, quality, and regulatory standards required for commercial medicine.

That's what makes the current moment so fascinating.

Cellares has raised hundreds of millions of dollars. It has built automated manufacturing systems. It has received FDA manufacturing recognition. It has manufactured cell therapy products that have reached patients. It has signed commercial agreements with biotech companies.

And yet one of the world's largest pharmaceutical companies just decided that the platform wasn't ready for its commercial Breyanzi manufacturing needs.

So I don't think the right conclusion today is that Cellares has failed.

And I don't think the right conclusion is that Cellares has proven its thesis either.

And over the next couple of years, we're going to find out whether Cellares was simply ahead of the industry—or whether it was trying to industrialize a biological manufacturing process that is fundamentally harder to automate than we thought.

This has been Petri Dish Perspectives. I’m Manead. Thanks for listening. See you next Thursday. Good bye.

References

1. https://www.cellares.com/ 
2. www.wikipedia.org
3. https://endpoints.news/ 
4. https://pitchbook.com/ 

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