Despite their groundbreaking potential, cell and gene therapies (CGTs) remain far from mainstream. Science is delivering, but the systems required to scale the science are not. At Endpoints Cell and Gene Day 2025, a panel of industry leaders tackled the issue head-on in a session sponsored by Ori Biotech: “Avoiding Failure: The Path to Commercial Viability for Cell and Gene Therapies.”
Moderated by healthcare journalist Surani Fernando, the session featured Marc Bamforth (CEO, Kincell Bio), Daniel Palmacci (Business Platform Head, Specialized Modalities, Lonza), Andrew Snowden (Senior Director, API Cell Therapy Development, Johnson & Johnson) and Jason C. Foster (CEO, Ori Biotech).
Summarizing the current landscape—”rushing to get clinical data without a plan for commercialization is a recipe for disaster”—Fernando reminded panelists and audience members alike of recent commercial challenges at companies like Bluebird, Iovance and Adaptimmune which demonstrate that investors aren’t rewarding approvals anymore unless there’s a clear path to both clinical and commercial success. The discussion centered on three key themes: scale, automation, and timing, all of which are closely interlinked.
Design for Scale from the Start
Too often, developers treat scalability as a post-approval problem. Snowden challenged that mindset early: “It’s absolutely key, and you really should be thinking about this almost before you go into the clinic with your Phase One drop,” he said. “You should be thinking about what it will look like commercially, and what it would mean to take a process that you’re developing from one patient today, to two patients a day, to 100 patients a month, 1000 patients a month, 10,000 patients a year…The longer you wait, making something truly scalable, the more you’ll be living with the consequences, and, unfortunately, the patients will too.”
Foster built on that urgency, arguing that scalability challenges in CGTs are fundamentally different from those in small molecules or biologics. “You can have a fantastically efficacious and safe medicine come out of the clinic,” he said, “but if you can’t make enough of it, and it’s too expensive from a cost-of-goods perspective, you run into commercial viability challenges.”
Bamforth pushed for pragmatic early action. “Test in an early pre-clinical stage, can work be done to mimic what scale up or scale out would look like for these products, to really confirm that they’re being developed on platforms that can be adapted,” he said.
He urged companies to model the cost of goods early and incorporate regulatory feedback and financial planning into preclinical strategies.
The takeaway? Developers who wait to plan for scale are locking in failure. Scalability isn’t a late-stage milestone, it’s a design principle that must shape decisions from day one.
Automation That Enables, Not Constrains
The panel turned to automation—framing it not as a buzzword, but as a make-or-break lever for reproducibility, efficiency, and regulatory confidence. “It is important to think about it early on,” said Palmacci. “It’s relying on very unique raw materials, equipment, and consumables… You need to find the right balance, and it’s not as simple as putting everything in a box and making it automated… Use the right automation tool at the right time.”
Snowden agreed, warning against narrow definitions of automation. “Automation is not just robotics,” he said. “It’s also figuring out whether it’s a step in your process, such as a step in media preparation or raw materials being used… You can think about this ahead of time and find something that is going to be a two-minute addition versus a two-hour pain, and that two-minute addition can be automated if you think forward.”
Thinking this way can be easier when you resist the urge to focus only on the rapid delivery of the final product, accepting relatively short delays to resolve critical issues. “Avoiding some trap doors that will basically derail your scalability, even the most trivial, that’s key,” said Snowden. “And now people are realizing that a little bit of time spent and a little bit of strategic thinking ahead of time doesn’t have to cost, but it will solve huge issues and make you much more streamlined in terms of your commercialization route.”
Bamforth emphasized automation’s role in consistency and control. “It reduces contamination risk, cuts variability, and boosts yield,” he noted, benefits that pay off in both scale and regulatory approval.
Foster reframed automation as a way to unlock productivity—freeing scientific talent, cutting manual labor, and reducing costs. Technology should serve as “an enabler, not a blocker,” empowering development teams rather than constraining them. “Today, micropipetting and tube welding are not the best use of a PhD immunologist’s time,” he said. “Let the technology do the grunt work so your experts can optimize the process and bring their expertise to bear.” He stressed the importance of maintaining flexibility in tech and service selection to retain control and drive better product outcomes.
In the past, automation tools required a trade-off between biological performance and flexibility in designing and optimizing processes, but that’s no longer the case. Today, therapy developers can adopt a flexible, modular approach that integrates best-of-breed technologies alongside expert service provision to achieve flexibility, reproducibility, and scalability, addressing some of the most common challenges in CGT manufacturing.
In a proof-of-concept study, Oribiotech in partnership with CTMC (a joint venture between MD Anderson Cancer Center and National Resilience) demonstrated technology transfer into process development in under two weeks and showed improved biological performance compared to legacy systems.
“This isn’t future state,” Foster noted. “This is happening now with next-generation platforms like IRO®.”
The Time is Now
So, when should developers tackle these challenges? The consensus: if you’re thinking about scale and automation after the clinic, you’re already too late.
“As you translate to commercial, that’s too late,” said Foster. Snowden echoed the sentiment: “The barrier to initiate and deploy [automation] is not huge… It’s better to learn the lessons in the first generation to get to the next before you’re constrained.”
Palmacci added that early doesn’t mean fully automated on day one, stressing that balance is key—what to automate, when, and at what points in the process. “You should have a strategy in place that can be iterated on and implemented step by step,” he said.
While not stated directly, the panel pointed to a broader industry reality: clinging to outdated tools, such as manual flasks or rigid end-to-end systems, can quietly lock in inefficiencies and risk. To keep pace with modern demands, developers need flexible, best-of-breed technologies that evolve in parallel with both scientific advancements and commercial strategies.
The New Standard for Patient Access
Bamforth closed by urging the industry to take a longer view. “It really takes lifting heads up and trying to look further ahead of what they’re going to need in the future to meet the patient demand,” he said, underscoring the importance of anticipating scale and infrastructure needs early, not just reacting to them later.
The panelists closed with a clear message: commercial viability doesn’t come after the clinic; it starts with early development planning. Therapy developers must design for scale, automate for consistency, and act with urgency. The playbook is changing. Purpose-built, automated, flexible technologies are replacing outdated systems and eliminating long-standing tradeoffs. What matters now is execution, focused on scalability, speed, and achieving widespread access for the patients who are counting on us.
Discover how IRO accelerates product development by enhancing throughput, reducing costs, and enhancing quality, from R&D to GMP.