Cell therapies have demonstrated remarkable clinical potential, but turning that promise into treatments that can be manufactured reliably and at scale remains a formidable task. Individual tools have become more sophisticated, but the wider process often still depends on manual transfers, fragmented data, and multiple systems that were never designed to work together. 

Edwin Stone has spent more than a decade approaching those challenges from an engineering perspective. After leading TTP’s cell and gene therapy team, he helped establish Cellular Origins to connect existing manufacturing technologies through integrated robotics and automation.

Here, Stone discusses why manufacturing progress has been slower than many hoped, the evolving investment landscape, and how collaboration, analytical innovation, and China could shape the next phase of cell therapy.

Could you tell us about your background and how Cellular Origins emerged from TTP?  

I’m an engineer by training. I completed a PhD in robotic vehicles at the University of Cambridge before moving into life science product development at TTP.

I spent more than 10 years working across product development, much of it focused on automation for cell-based workflows. That eventually led me to work on what later became the first EMA approved cell therapy. As an engineer, I found the biology almost like science fiction. I had seen plenty of impressive biology before, but nothing quite as remarkable as cell therapy. At the same time, it was clearly an enormous engineering challenge.

That experience led me to establish TTP’s cell and gene therapy team. We developed several tools that are now used across the sector, including in commercial manufacturing. But these were largely highly capable islands of automation: an automated bioreactor, cell separator, or gene-editing system. We still needed an army of people to connect everything together. Operators were manually moving consumables between systems, making sterile connections between process steps, and managing fragmented data.

We spent considerable time speaking with therapy developers and equipment providers to validate the problem. Initially, we assumed someone else would solve it, but eventually it became clear that no single company could. Therapy developers wanted the best tool for each stage, not an entirely proprietary platform. Equally, companies reaching late-stage clinical development were not going to replace processes they had spent years optimizing simply to adopt a new manufacturing system.

That realization was the starting point for Cellular Origins. The company developed gradually within TTP while we explored potential solutions, built industry relationships, and secured commercial interest. That gradual process is one reason I think spinouts can be so effective, particularly in a constrained funding environment: they allow a business to validate the need and reduce risk before formally launching.

What ultimately triggered the spinout was the signing of significant commercial contracts. Cellular Origins began operating independently in 2024, but unlike a typical startup beginning with an idea and a funding round, we already had meaningful revenue.

How has the investment environment for advanced therapies changed over the past five years or so? 

You can view it either way: we’ve either been incredibly lucky or incredibly unlucky.

During the funding bubble, I was still leading the cell and gene therapy team at TTP. We benefited from that environment and helped companies raise some very large rounds. By the time Cellular Origins began looking for external capital, however, the market had changed significantly. We already had customer funding, so we were not raising money simply to survive. Our aim was to bring in capital that could accelerate growth, and we set a high bar for doing so. That put us in a stronger position than companies whose only source of income was investment.

When we began engaging more deeply with investors in 2024, I saw capital “moving right”: investors increasingly wanted proven revenue, profitability, and market fit. Some funding was still available at the earliest stages, usually through relatively small seed rounds, but the middle had become much more difficult. Companies either had to give away a significant stake very early or become considerably more mature before attracting meaningful investment.

We were fortunate because we already had much of the commercial proof investors were looking for. Johnson & Johnson was also one of our key partners and ultimately led our investment round alongside a syndicate of growth investors suited to the stage of the business.

The broader lesson is that investors now place much greater value on commercial evidence. That inevitably means some good companies will struggle to raise capital, but I do not think greater discipline is necessarily a bad thing. Businesses are being forced to think more carefully about what they spend, where revenue will come from, and how they can generate it earlier.

That is particularly relevant in biotech, where some companies invested heavily in manufacturing capacity before knowing whether their therapies would reach commercial approval. When interest rates rose, sectors that had used capital inefficiently were hit especially hard, and advanced therapies felt that pressure particularly strongly.

How would you assess the rate of progress in cell therapy manufacturing?

Investors have relatively short attention spans, and capital is finite. When a sector does not advance as quickly as expected, investment tends to move elsewhere, and I think that is what has happened.

Part of the problem was a lack of understanding about what the solution should look like. It took me a while to realize that it was not going to be a magical new manufacturing paradigm. Therapy developers spend years optimizing these products, and even on a relatively fast path it may take around 10 years to move from preclinical work to a late-stage clinical asset. 

By that point, developers are not going to abandon the tools and processes they have spent years refining. They have selected the best equipment for each stage and built a process around producing the most efficacious therapy. Switching to an entirely new manufacturing model late in development would introduce too much risk and delay.

Much of the underlying science has already been established, but it now needs to be paired with effective and efficient engineering. One principle we set for ourselves at Cellular Origins was to invent as little as possible. That may sound odd, but other industries already use highly capable automation technologies that have barely been applied in pharmaceutical manufacturing, let alone cell therapy. Mobile robots are a good example. Billions of dollars have been invested in making them highly effective in warehouses, automotive plants, and semiconductor facilities, yet they remain rare in bioprocessing.

The challenge is adapting those technologies to the specific needs of cell therapy manufacturing. We have had to develop new capabilities – particularly around sterile fluid transfer, cleanliness, and data integrity – but our broader aim is to build on the enormous investment that has already gone into advanced automation elsewhere. 

The problem is therefore less about fundamental invention than integration. Bringing equipment, operational systems, and data together is complicated, and the sector is having to blaze a trail because these technologies have not previously been integrated at this scale. 

Around 12 months ago, we deployed our first systems to the Cell and Gene Therapy Catapult, where they have now been operating for almost a year. We will deliver our first systems across the Atlantic early next year. 

What other challenges still need to be solved alongside manufacturing automation? 

Around half of the labor involved in these workflows can sit on the analytical side, so those with long experience in cell therapy rightly point out that automating manufacturing alone is not enough. The encouraging part is that much of the analytical workflow looks relatively familiar, involving liquid-handling robots, cytometers, cell counters, and other technologies already widely used in laboratory automation. In many cases, the analytical workcell does not require a fundamentally new invention.

The gap is in connecting it to the manufacturing process. You need to take a sterile sample from the process and transfer it reliably into the analytical workcell without compromising the product or the data. That is an area where we have developed technology, and it is essential if we are to ensure that analytics does not become the next bottleneck.

The more difficult scientific challenge is sterility release testing. Measurements such as cell count, viability, and phenotype are well established, but conventional sterility testing can take a week or longer because you are effectively waiting to see whether microorganisms grow. For autologous therapies, where vein-to-vein time is already critical, that delay is a major constraint.

There is interesting work underway to shorten that timeline. SymCel, for example, uses calorimetric measurements to detect the heat produced by early microbial growth, alongside algorithms intended to provide information about the types of organism present. 

For me, that is one of the next frontiers. If we want to reduce vein-to-vein times and avoid releasing products before sterility results are available, we need faster and sufficiently sensitive release assays. So there are really two analytical challenges: integrating established assays into automated manufacturing and developing faster approaches to sterility testing.

Over the next five to ten years, do you think we’ll see greater adoption of these technologies and start to solve that complexity problem?

I’d go even further – I think it could happen in the next two years. 

What the field needs most is a boost in confidence. There is little doubt around the science anymore; we know these therapies can be highly efficacious and, in some cases, substantially outperform the standard of care. The safety profile has also improved over the past two or three years. In the early days, there were major concerns around cytokine release syndrome and related risks, but the field is becoming much better at managing them.

For any therapy, the two central questions are efficacy and safety, and products are continuing to improve on both fronts. What the industry still needs to demonstrate is that those therapies can be manufactured reliably at scale. As technology providers, we have a responsibility to prove that the manufacturing challenge is solvable. 

That evidence matters not only to investors, but also to big pharma, which will ultimately be responsible for bringing these therapies to patients at scale. Big pharma is still investing heavily in the field, including in new manufacturing capacity, which suggests that significant confidence remains. The next step is proving that scalable manufacturing can deliver on that promise.

No single organization can solve the challenge alone. At Cellular Origins, we work closely with partners such as Cytiva, Fresenius, ThermoFisher and ScaleReady, with each organization contributing its own expertise. Progress depends on understanding where each company can add the most value and how those capabilities can be brought together.

Looking ahead, what is the main focus for Cellular Origins?

Last year, we delivered our first system. Over the next year, our focus is getting the first systems across the Atlantic and into facilities manufacturing doses for clinical use. As much as I support UK plc, the US is where much of the most substantive activity is currently happening. A significant proportion of our revenue already comes from US businesses, and we recently launched Cellular Origins Inc. as the first step toward establishing a permanent presence there.

International expansion is important, but the central objective is to prove what I described earlier: that these therapies can be manufactured through an integrated, automated process. We are now very close to doing that.

More broadly, what gives me confidence is how much exciting work is underway and how much remains to be done. The cell and gene therapy industry sometimes sees itself as more mature than it really is. The first major therapies were approved less than 10 years ago, and that is not a long time in which to build an entire industry. Sometimes we are too hard on ourselves because we have not solved every problem yet, but these things take time.

It is not only about technology. The industry is also still working out how different organizations should collaborate, and I think that will be one of the defining themes over the next few years. The willingness of equipment providers, therapy developers, and technology companies to contribute their own expertise is very encouraging.

We are still near the beginning of this journey, but the foundations are now being put in place. That gives me confidence that progress can begin to accelerate. 

Newsletters

Receive the latest pharmaceutical news, personalities, education, and career development – weekly to your inbox.

I have read and understand the Privacy Notice*

Subscribe