Personalized cell therapies have emerged as powerful treatments for cancers and other diseases but producing them remains a complex engineering challenge. Unlike conventional drugs, each cell therapy dose is manufactured from an individual patient’s cells through a multi-step process that is often performed manually in specialized clean rooms. Cellares is working to industrialize this process with automated, closed manufacturing systems such as its Cell Shuttle platform and automated quality control technology, Cell Q.
Fabian Gerlinghaus
Cofounder and Chief Executive Officer
Cellares
In this Innovation Spotlight, Fabian Gerlinghaus, the cofounder and chief executive officer of Cellares, discusses how better automated systems can increase production capacity, reduce variability, and support a globally distributed manufacturing network.
What are the biggest bottlenecks that delay patient access to cell therapy?
The science works; we have US Food and Drug Administration (FDA)-approved cell therapies that can cure cancers where chemotherapy has failed. Patients are dying on the waitlist right now, not because the biology failed them, but because the industry cannot manufacture enough doses to treat them.
The bottleneck is entirely industrial. These therapies are still made by hand, one patient at a time, in clean rooms that require large teams, expensive infrastructure, and weeks of manual labor. When the entire industry produces around 10,000 patient doses a year across all approved products, and a single autoimmune indication can have a patient population of 100,000 per year per drug, the math simply does not work.
The problem is variability and capacity. Manual processes introduce inconsistency, contamination risk, and failure rates that can reach 30 to 40 percent in some cases. That is not a sustainable model for any medicine, let alone one where every failed batch means a patient may not get another chance. Until we replace artisanal manufacturing with automated, closed, and scalable systems, cell therapy will remain a niche treatment rather than a widely accessible medicine.
How does cell therapy manufacturing differ from the manufacture of other therapeutics?
Cell therapies are living drugs. That is a fundamentally different challenge from anything else in medicine.
With small molecules, you synthesize a compound. With biologics, you grow the product in large bioreactors and one manufacturing run can yield doses for millions of patients. Cell therapies are nothing like that. Every dose starts with cells taken from an individual patient, and every one of those doses must go through a complex, multi-step manufacturing process under strict conditions, often over many days, with dozens of manual interventions.
Instead of producing thousands of identical units from one batch, you are producing unique, patient-specific products, each from its own manufacturing run. The risk of failure increases at every step. A contamination event, a handling error, or a deviation in any of those manual steps, and that patient’s therapy is gone.
That is why automation, closed systems, and reproducibility are not just nice to have in cell therapy, they are existential requirements. No other drug class demands this level of per-unit precision at this scale. The engineering challenge is genuinely new, and the industry is only beginning to solve it.
Because each cell therapy dose is made from a patient’s own cells, these personalized medicines require highly controlled manufacturing processes, which is driving the development of automated platforms designed to produce individualized treatments at scale.
©iStock, SeventyFour
What are the main technical and regulatory hurdles to automating cell therapy manufacturing?
On the technical side, the core challenge is replacing dozens of discrete manual steps with a fully integrated, closed, and automated workflow that can handle the enormous variability across different cell therapy types and patient starting materials. Most instruments on the market today automate one or two unit operations for one patient at a time. That is an incremental improvement, not a solution that will solve the manufacturing bottleneck. What you need is end-to-end automation, where the entire manufacturing process happens inside a closed system with no open transfers, no manual handoffs, and no opportunity for contamination or operator error.
The second technical challenge is quality control. A lot of people talk about automating manufacturing and then forget that every batch must still go through a battery of release assays on more than a dozen instruments, with teams generating hundreds of pages of paper-based batch records by hand for every single patient. If you automate manufacturing but leave quality control manual, you have just moved the bottleneck downstream. Both halves of the pipeline must be automated together.
On the regulatory side, the FDA has set a high bar for validating a living product made by a novel automated platform. That is appropriate. You need extensive data from end-to-end runs demonstrating that your automated process meets all critical quality attributes and delivers a product that is comparable to, or better than, what was produced manually. The process we went through to earn the first FDA Advanced Manufacturing Technology (AMT) designation required rigorous data generation, rounds of information requests, and deep collaboration with regulators. But the payoff is real. The designation provides our customers with expedited review of their regulatory filings and confidence in the platform they are building.
What is needed to scale cell therapy safely?
Three things must come together.
First, there needs to be a fully closed manufacturing system. Open transfers between instruments are where contamination happens. Every time a human operator moves cells from one benchtop instrument to the next, you introduce risk. A closed, pre-sterilized system eliminates that vulnerability. The FDA has confirmed that the consumable cartridge of our Cell Shuttle platform constitutes a fully closed system, which also means that we can run multi-patient, multi-product manufacturing concurrently without cross-contamination risk.
Second is comprehensive automation that removes human variability from the equation. Human operators are skilled, but simply inconsistent over time, across shifts, and across facilities. Automation is the only way to achieve the reproducibility that cell therapy demands to scale. Our analysis suggests automation can reduce process failure rates by up to 75 percent compared to manual methods. That is the difference between a viable industry and one that cannot deliver.
Third, we need a globally distributed network of GMP facilities where the identical manufacturing and quality control protocols run the same way in New Jersey, in the Netherlands, and in Japan. One of the structural advantages of full automation is that tech transfer becomes a software operation. You do not retrain thousands of people in a new facility. You deploy the same hardware, transfer the protocols digitally, and the Cell Shuttle in Europe does exactly what the Cell Shuttle in New Jersey does. That is how you build a global supply chain for personalized medicine.
Where does Cellares fit into this landscape, and what makes your approach unique?
Cellares was built from day one to be the industrial backbone of cell therapy manufacturing globally. We are not building a benchtop instrument for one step in the process. We built the Cell Shuttle, which automates the entire manufacturing workflow from start to finish for up to 16 patients simultaneously. We also built the Cell Q, which automates quality control for up to 6,000 patient doses per instrument per year. Both technologies are cGMP-compliant and commercially ready.
The numbers tell the story. A single Cellares facility can produce as many cell therapy doses as 10 manual facilities, using roughly 10 percent of the staff and 10 percent of the space. This is how we enable the lowest manufacturing cost compared to both conventional CDMOs and in-house manufacturing.
What makes us genuinely unique is the combination of throughput, end-to-end automation including quality control, and global reproducibility through our Smart Factory network. We have facilities under construction in the United States, Europe, and Japan. Once a customer’s process is on the Cell Shuttle, we can deploy it to any of those sites at the push of a button. No repeated tech transfers, no retraining thousands of people, and no regulatory surprises. That is something no one else in the industry can offer today.
cent success rate in automating a dozen different customer processes on our platform so far. That track record matters when biotech and pharma companies are making decisions about where to stake their commercial-scale manufacturing.
What excites you most about the next 5 to 10 years in this field?
We are entering the industrial era of cell therapy, and I think the next decade is going to look nothing like the last.
The science pipeline is extraordinary. Cell therapies are moving beyond hematological malignancies into solid tumors, autoimmune diseases, rare diseases, and into indications where patient populations are not 10,000 per year but 100,000 per year per drug. The demand that is coming will dwarf what the industry has ever produced.
What excites me the most is that for the first time, the manufacturing infrastructure is being built to meet that demand. When manufacturing is no longer the rate-limiting step, the trajectory of these therapies changes entirely. They move earlier in the treatment pathway, from last resort to frontline option. More patients get access, costs come down and the payer conversation changes.
Personally, I am most excited about autoimmune disease. Carl June, who has been an advisor to Cellares for more than five years, has talked about what it would mean to cure autoimmune diseases the way we are beginning to cure certain cancers. The patient populations are enormous, the unmet need is real, and the early clinical data is remarkable. If manufacturing can keep pace with that science, we will be looking at a completely different world for patients a decade from now.
Is there anything else you would like readers to know?
Cell therapy has already cured patients who had no other options. I have lost grandparents to cancer. Many people reading this have their own version of that story. These treatments are real, they work, and they are on the market today. The barrier is not the science anymore.
The barrier is manufacturing, and manufacturing is an engineering problem, but engineering problems have solutions.
What we are building at Cellares is the automation-native infrastructure that makes it possible for every patient who needs a cell therapy to actually receive one on time, at a price the system can sustain, anywhere in the world. That is the mission: to meet the global patient demand.
