Why the Need to Expand Industry Focus Beyond Gene Editing Toward Scalable Cell Therapy Manufacturing?

Advances in cell therapy development are increasing pressure on manufacturers to align scientific innovation with scalable production strategies, according to Edwin Stone, PhD, CEO, Cellular Origins, Speaking at the 2026 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting, which was held May 11–15 in Boston, Dr. Stone said the field is moving beyond a narrow focus on single therapeutic modalities and toward broader manufacturing considerations that support commercial deployment.

In an interview with BioPharm International® Dr. Stone notes that developers are increasingly exploring multiple delivery and editing approaches simultaneously, including adeno-associated virus, lipid nanoparticles, allogeneic platforms, autologous ex vivo therapies, and in vivo approaches. The expansion of available tools is allowing researchers to pursue more sophisticated cellular edits and potentially broader therapeutic targets, he says.

“Our focus is very much on industrializing cell therapy manufacturing,” Dr. Stone states. “We take existing processes—we're not developing new bioreactors and new tools—but what our focus is is taking the tried and tested tools, the tried and tested biology, some of the great breakthroughs that we're seeing here at places like ASGCT and enabling the manufacturing of that at scale using robotic manufacturing.”

How are manufacturing requirements reshaping cell therapy development strategies?

According to Dr. Stone, one of the most significant shifts in the cell and gene therapy sector is the growing integration of manufacturing considerations into early-stage development planning. He notes that scientific and engineering disciplines have historically operated separately, but developers are increasingly recognizing the need to evaluate scalability alongside therapeutic efficacy.

Dr. Stone also describes stronger engagement from early-stage developers at the annual meeting, particularly around questions involving manufacturability, scalability, and development strategy selection. He characterizes this trend as a positive evolution for the industry, particularly as cell and gene therapy developers seek to address longstanding production bottlenecks.

Dr. Stone also points to increasing use of clinical and post-approval commercial data to guide modality selection for specific indications. While in vivo approaches continue to generate significant interest, developers are not abandoning allogeneic or autologous platforms he emphasizes. Instead, companies are assessing which modalities are best suited for particular biological and manufacturing challenges.

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About the speaker

Edwin Stone, PhD, CEO, Cellular Origins

Dr. Stone has spent more than 20 years bringing new life science technologies to market, the last 10 of these focused on solving the challenges of cell therapy manufacturing. He established TTP’s cell and gene team which developed more than 10 cell therapy automation systems, including systems that are now in routine use for commercial therapy manufacture. Seeing the challenge of scale remained unaddressed, Dr. Stone co-founded Cellular Origins to enable patient access to cell therapies through scalable, cost-effective, and space-efficient manufacturing enabled by the Constellation automated cell therapy manufacturing platform. Dr. Stone holds a master’s degree in engineering and a PhD in robotic vehicles from the University of Cambridge.