Flexibility and scalability are critical to the success of cell and gene therapy manufacturing

While the cell and gene therapy (CGT) sector continues to achieve major regulatory milestones and the clinical pipeline is robust, challenges remain for manufacturing these potentially life-saving modalities, according to panelists at the 2025 Meeting on the Mesa, held this week in Phoenix.

Although these potentially curative therapies offer hope to millions of patients, including those with cancer and other difficult-to-treat diseases, they remain complex and difficult to manufacture with scale-up frequently an obstacle to regulatory approval and commercialization.

A panel on Monday at the Meeting on the Mesa, hosted by the Alliance for Regenerative Medicine, laid out the challenges and opportunities facing the industry as it looks to produce these therapies at scale.

“The infrastructure around these therapies just hasn’t kept pace with the pace of the science,” according to Ori Biotech CEO Jason Foster. “It’s this kind of difficult tradeoff that developers have to make sometimes between biology and automation or flexibility and the desire to scale at some point.”

Foster contends that there’s a new standard for manufacturing that “doesn’t force developers into that difficult decision — the idea is to provide flexibility and scalability at the same time.” That capability is the hallmark of CGT 2.0, he said.

Tom Wilton, senior vice president of innovation ventures at Children’s Hospital of Philadelphia, observed that manufacturing remains a challenge despite the “incredible progress over the last 10 to 15 years with commercial-scale products.” Wilton said that “it costs too much to develop these therapies” while Cost of Goods Sold (COGS) for CGTs is “still too high” to see widespread adoption.

However, Wilton made the case that “flexibility moving forward is around defining systems that are interoperable, modular, and we can use for different product types” including digital technologies to help reduce time and COGS, while improving the quality of the output.  

Digitalization is gaining traction in production workflows and is redefining CGT manufacturing, according to Andrew Snowden, senior director for allogeneic and autologous cell therapy development at Johnson & Johnson Innovative Medicine.

“You have to really think about true end-to-end systems and how do you drive down the complexity and down the costs,” Snowden said. “The big lesson is: if you have manual processes, batch records that are not streamlined and optimized, all these kinds of things will pinch you and it will become a huge sink from a quality, release, and actual scalability perspective.”   

Manufacturing challenges, digital solutions

Cytiva on Monday released results of its survey of 1,250 biopharma executives across 22 countries and found that while capacity is expanding, manufacturing agility has declined posing challenges for companies looking to scale production efficiently. For newer modalities such as CGTs, Cytiva’s data also provided evidence that the challenge is compounded by a lack of standardization.  

“2025 data shows that many firms lack the ability to scale production quickly,” according to Cytiva. “One in four executives surveyed said their organization would be slow or very slow to ramp up manufacturing of hormone-based products, mRNA vaccines, and cell and gene therapies.”

However, Cytiva’s data reveals that high-growth organizations are more likely to leverage digital technologies across multiple manufacturing areas compared to underperformers, providing “clear advantages” in biopharma manufacturing, from improved batch consistency and faster release timelines to reduced downtime and waste.

“Automation and digital analytics will be central to scaling living therapies like CGTs,” Michael May, CEO of the Center for Commercialization of Regenerative Medicine states in the Cytiva report. “It’s not just about how you make them, it’s how you monitor and release them that matters.”

Automation and analytics are key to scaling CGTs, according to May.

“There’s still so much to do on automation, including biosensors that can monitor in real time what’s happening as cells are being produced,” May said. “Then there’s analytics and being able to characterize cell and gene therapy products, as they’re living and changing all the time. Everyone talks about automating manufacturing, but we also have to automate analytics.”

Ken Harris, chief strategy officer and head of AI at OmniaBio, told Monday’s panel at the Meeting on the Mesa that automation has existed for decades in other industries.

“You can create a very complex product end to end with no humans involved,” Harris said. “I don’t think that’s what we’re ready for. There’s always going to be a human in the loop, at least in my lifetime, in healthcare.”

At the same time, he noted the “low-hanging fruit” in CGT manufacturing can be found in manual processes “where we can improve quality and probably improve cost right away — that everyone can buy into.”