Cell Therapy Works. The Facility Doesn’t. Cellares Is Redesigning the Infrastructure.

Cell and gene therapies have crossed a scientific threshold. CAR-T therapies are approved by regulatory agencies around the world. Gene editing is no longer theoretical. Hematopoietic stem cell (HSC) programs are advancing beyond proof of concept. The biology works. But the systems that deliver it remain strained.

For Fabian Gerlinghaus, the disconnect became clear in 2017, when the first CAR-T therapy received U.S. Food and Drug Administration approval. At conferences, he recalls, the tone was celebratory—but uneasy. “People were shouting from the rooftops: we’ve got cures for cancer — and we don’t have a way of manufacturing them at commercial scale or at a sustainable cost.”

That contradiction, clinical breakthrough paired with industrial fragility, became the founding thesis of Cellares. The next phase of cell therapy would not hinge on discovering new targets alone. It would hinge on whether the industry could build manufacturing infrastructure capable of delivering those therapies at scale.

When Science Outpaces Infrastructure

Cell therapies are no longer speculative science. “Cell therapies at this point are an established asset class,” Gerlinghaus says. “The science has proven to cure very aggressive forms of blood cancers.” The modality is expanding into solid tumors, autoimmune diseases, and gene-edited rare disease programs.

Cell therapies are personalized medicines which means that every dose is made to order for each patient individually. Commercial-scale manufacturing requires high-throughput automation, yet manufacturing remains largely manual. Many workflows are still executed with operators executing open processes with manual benchtop equipment in cleanrooms. Batch failures can occur due to contamination, variability in operator handling, or supply chain interruptions in single-use components. Facilities must hire and train large technical teams to sustain throughput.

“Manufacturing cell therapies manually, one patient at a time, with really complicated processes,” Gerlinghaus says, “is just not scalable and not sustainable from a cost perspective.”

Real-world examples illustrate the pressure. Some commercial autologous therapies have required thousands of highly trained operators per facility. Scaling into new geographies often means duplicating cleanrooms and retraining entire workforces. In a modality where vein-to-vein time matters, process delays translate directly into patient risk. Meanwhile, high manufacturing costs contribute to therapy price tags that approach or exceed seven figures.

The science may have matured, but the industrial backbone has not kept pace.

From Aerospace Engineering to Cell Therapy Factories

Gerlinghaus did not arrive in biotech through traditional biology training. Educated as an aerospace engineer in Germany, he built his early career around robotics and control systems before moving to California. Automation, rather than therapeutics, was his starting point.

“I was always fascinated by automating things,” he says. “I was looking for a problem that was really worthwhile automating.”

Cell therapy manufacturing presented exactly that. “The problem of how to manufacture cell therapies at scale and with lower cost screams for automation. It’s the only way to solve this problem.”

But automating only one manufacturing step at a time, he argues, is insufficient. Many companies have attempted to automate isolated steps—cell sorting, electroporation, expansion—while leaving the broader workflow fragmented. Cellares instead approached the problem as a holistic infrastructure challenge.

“The core thesis was we need to automate and close the process entirely while increasing the throughput,” he says. “Automation eliminates human error. Closing the process eliminates contamination.”

The company built integrated systems, rather than layering automation onto legacy instruments, and designed the platform so that customization occurs at the level of digital process programming rather than hardware redesign. “We’ve transitioned the problem of platform customization from hardware into software,” he explains.

Why 2017 Was the Turning Point

Timing proved decisive. Before 2017, cell therapies were largely produced in academic or early clinical settings for a few dozen patients at a time. “Nobody had the problem of scaling this up to hundreds of thousands of patients per year per drug,” Gerlinghaus says. Once commercial approvals arrived, the industrial question became unavoidable.

“That problem only exists as of 2017,” he notes. “Five years earlier, we would have been too early. Five years later, we would have been too late.”

The industry understood that manual models were unsustainable. What stalled progress was not insight but execution. Rebuilding manufacturing architecture requires deep capital investment, long development timelines, and tolerance for regulatory scrutiny. It also demands interdisciplinary integration: cell biologists working alongside mechanical and software engineers from day one.

When Cellares began integrating multiple core technologies into a unified system, skeptics questioned whether it could be done within competitive timelines. “You guys are positively nuts,” Gerlinghaus recalls being told.

Today, the company operates in GMP environments and manufactures clinical cell therapy products. “We’re not talking about a concept anymore,” he says. “We’re making drugs for patient infusion.”

Rare Diseases as Structural Test Case

While oncology remains a major focus, Cellares’ platform now supports gene-edited HSC therapies for rare diseases such as sickle cell disease, beta thalassemia, SCID, and HIV. Rare diseases are often discussed as niche markets, but Gerlinghaus challenges that assumption.

“If you sum up all rare diseases together as a class, they’re not actually rare,” he says. “Three to five percent of the world’s population suffers from at least one rare disease.”

From a manufacturing perspective, rare diseases present a particular stress test. Patient populations are small, regulatory oversight is intense, and there is little tolerance for variability. Each program may target a different gene, but the underlying manufacturing backbone remains similar.

“The manufacturing workflow for a CAR-T and for a hematopoietic stem cell therapy is very, very similar,” Gerlinghaus explains. “It’s purification, genetic manipulation, incubation, cryopreservation, and quality control.”

If the architecture remains constant, only the genetic construct changes. “Same manufacturing process every time. All you switch out is the gene of interest.”

In regulatory terms, this raises the possibility that over time, review processes may focus less on revalidating the entire manufacturing system and more on the incremental genetic and clinical variables.

From Breakthrough to Backbone: The Industrial Roadmap for Cell Therapy

If cell therapy is to transition from breakthrough science to durable infrastructure, the shift must be architectural. Industrialization is not about making therapies faster, it is about making them reliably, repeatedly, and at scale. The roadmap emerging across the sector reflects hard-earned lessons from real-world bottlenecks.

1. Close and automate the system – Eliminate open, operator-dependent steps to reduce contamination risk.
2. Build high-throughput manufacturing technologies – Develop automated platforms capable of processing multiple patient doses in parallel within a controlled, closed system.
3. Integrate QC with production – Embed analytics into the workflow rather than conducting batch-end validation only.
4. Digitize process control – Standardize manufacturing logic so it can be replicated across sites.
5. Replicate infrastructure globally – Expand by duplicating validated systems, not redesigning facilities.
6. Standardize early-stage pathways – Provide predefined manufacturing templates to accelerate biotech entry into the clinic.

Industrialization does not remove biological complexity. It contains it within a controlled, repeatable framework, transforming fragile innovation into sustainable therapy.

Global Replication and Economic Reality: Tech Transfer at the Click of a Button

Cellares is expanding operations across the United States, Europe, and Japan, including through a publicly disclosed $380 million agreement with Bristol Myers Squibb. Automation, Gerlinghaus argues, changes how expansion works.

“With automation, we can tech transfer at the click of a button,” he says. Digital replication allows identical workflows to run across geographies. “Our automated platforms will do the exact same thing in Europe and Japan that they did in the United States.”

In traditional manual models, expansion can take years and require hiring and training large technical teams in each region. Earlier international launches can significantly affect revenue timelines for pharmaceutical partners. “If we can launch in Europe and Japan a few years earlier,” he notes, “that saves countless patient lives and unlocks billions of dollars per year for our customers.”

But beyond revenue, the question is patient access. Earlier geographic replication means shorter waits for therapies in markets that historically lag behind U.S. approvals.

What Automation Does Not Solve

Automation does not eliminate every bottleneck. Reimbursement models remain complex. Global regulatory harmonization is uneven. Supply chains for viral vectors and gene-editing reagents can still constrain throughput. Cost-of-goods reductions do not automatically translate into lower therapy prices.

Gerlinghaus acknowledges that further standardization across the ecosystem is needed. Early-stage biotechs often lack defined CMC strategies, leading to expensive redesigns later. “You can come to us and leverage standardized processes to get to the clinic much, much faster,” he says. “With a much smaller team.”

But infrastructure alone cannot resolve broader systemic incentives. It can only remove one of the largest structural barriers.

Engineering With Purpose — Turning Manufacturing Architecture Into Patient Access

Gerlinghaus’ personal motivation intersects with the industrial mission. He lost two grandparents to cancer. Making curative therapies broadly accessible is not abstract. “Making cures for cancer available to hundreds of thousands of patients each year is a worthwhile cause,” he says. “It’s a cause worth dedicating a career to.”

Still, the central theme of this conversation is not personal narrative. It is industrial evolution. Cell therapy has demonstrated scientific credibility. The open question is whether the industry can industrialize it without compromising safety, regulatory rigor, or global equity. As Gerlinghaus frames it, the debate is no longer about whether the therapy works. It is about whether the system can deliver it.

Author

Bernice Lottering

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