In cell and gene therapy (CGT), the science is working – but the system isn’t.
As Tim Hunt, Chief Executive Officer of the Alliance for Regenerative Medicine, put it, “The status quo in cell and gene therapy for most patients today represents death or serious disability.”
Globally, fewer than 5% of patients who could benefit from approved cell therapies like CAR-T have been able to access them. Around 900,000 people could be eligible worldwide, yet only ~45,000 have been treated.
The issue isn’t scientific progress – it’s economics. Many approved treatments remain out of reach because the manufacturing processes behind them are still too complex, manual, and costly to reproduce at scale – preventing them from becoming commercially viable, and limiting both availability and affordability.
The limits of CapEx and OpEx in cell therapy manufacturing
For most developers, the biggest financial challenge isn’t producing the first clinical trial batch – it’s producing the next hundred. Or the next thousand.
The high cost of manufacturing cell therapies remains the biggest barrier to access. But while the industry has long focused on capital expenditure (CapEx) and operating expenditure (OpEx) as indicators of cost, they don’t capture the full complexity of delivering CGT at commercial scale.
That’s where Total Cost of Ownership (TCO) comes in.
TCO goes beyond upfront investment and annual operating spend. It looks at the true cost of bringing a therapy from early therapy development to commercialization: across equipment utilization, facility footprint, training, process changes, scalability, and batch failure.
What drives manufacturing costs in cell and gene therapies?
While different types of cell and gene therapies carry different challenges, most cost structures are shaped by the same three key cost drivers:
- Consumables (cost of goods e.g. media, reagents, viral vectors)
- Labor (manual handling, QA/QC, cleanroom operations)
- Infrastructure (footprint, layout, and grade requirements)
Once a commercial manufacturing process is built around open, manual processes, it becomes harder – and more expensive – to scale them up, or change them, further down the line. This is one of the key reasons so many advanced therapies stall, despite showing strong clinical promise.
How IRO® supports scalable cell and gene therapy manufacturing
Ori’s IRO platform was designed to help therapy developers address cost, complexity, and reproducibility across the full manufacturing workflow. By aligning biological performance, automation, and facility efficiency within one system, IRO provides the foundation needed to scale CGT manufacturing without compromising quality or flexibility.
Improving biological consistency reduces overspend. Inconsistent processing – particularly at expansion and harvesting stages of CGT development – can cause teams to burn through reagents and consumables at a high rate. IRO was built to support reproducible biology and robust cell growth from the start, which helps reduce reruns and improve batch efficiency.
Automation reduces labor without losing flexibility. By automating the most time- and labor-intensive steps, IRO lowers the hands-on burden by up to 70%. This not only improves reproducibility – a long-standing issue across many cell therapy modalities – but also lays the foundation for scalable production.
Closed systems reshape facility costs. Legacy systems often rely on Grade A/B environments. IRO’s closed design enables developers to shift to Grade C/D, opening the way for more efficient manufacturing facilities without compromising quality.
Modular scale without new buildings. Instead of scaling by expanding the footprint, IRO allows developers to scale by stacking capacity. Its compact, modular design supports high throughput in existing space, which can be a game-changer when bringing cell and gene therapies to market in a space-constrained environment.
Design over cost: why TCO matters more than ever
Cell and gene therapy manufacturing doesn’t just have a cost problem – it has a systems problem. TCO highlights the long-term penalties of working without automation or digital infrastructure. The longer a program runs without scalable design, the more expensive it becomes to correct.
That’s what IRO designed to prevent. A closed, automated, and modular platform that helps developers reduce cost per dose by up to 40%, while increasing consistency and reducing failure risk.
This is what CGT 2.0 looks like: building smarter systems for scalable access.
Find out about how we are enabling cost-efficient CGT manufacturing