CGT Manufacturing Shifts Toward Industrialization and Process Consolidation

Cell and gene therapies are entering a new phase in which sustainable commercialization depends on manufacturability at scale, with industry leaders converging on the need to reduce operational complexity while improving reproducibility through consolidated unit operations, modular closed workflows, and digital quality systems.

Insights from the Advanced Therapies USA conference in Philadelphia highlighted that industrialization is needed across viral and nonviral delivery, adherent-cell expansion, and next-generation CGT manufacturing. Attendees suggested that 2026 will reward programs that build repeatability early rather than retrofit it late.

For much of the past decade, advanced therapies were judged primarily on whether they could work biologically, but that criterion alone is no longer sufficient for program success. Manufacturing leaders, regulators, and health systems are converging on a more demanding test: Can a CGT be produced reliably, repeatedly, and at a cadence and cost that supports routine care?

A director of business development at gene therapy contract development and manufacturing organization ReiThera identified three key themes from the conference: the push toward scalable, industrialized manufacturing for CGTs, the emergence of next-generation delivery platforms and nonviral approaches, and a growing emphasis on regulatory clarity, patient access, and real-world implementation.

Process consolidation emerged as a recurring theme because it addresses several constraints simultaneously: labor intensity, cleanroom burden, variability introduced during open handling, and the accumulating documentation load that can slow down investigations and release. The general manager of the cell and gene therapy business at Terumo Blood and Cell Technologies highlighted a "growing focus on simplifying complexity in advanced-therapy manufacturing, particularly through process consolidation, bringing multiple steps into a more streamlined workflow. This isn't just about efficiency; it also reduces variability and creates more predictable scale-up pathways, which is critical as therapies move toward commercialization."

That is especially true for cell therapy manufacturing, in which each additional handoff, centrifugation, transfer, open manipulation, or manual sampling event expands the potential for failure. Such complexities also increase dependence on highly skilled operators and add opportunities for shift-to-shift variability. To accelerate adoption of simplified, reproducible manufacturing methodologies across the ecosystem, ScaleReady has established the G-Rex Grant Program, a US$40 million initiative. With the company's platform already used by more than 800 organizations, the grant program represents a deliberate effort to embed simplified, reproducible cell-expansion methodology at the earliest stages of development, before costly manufacturing habits become entrenched.

At the conference, a University of Chicago professor and Terumo BCT partner shared new data on an approach to integrating activation, transduction, and expansion into a single workflow for T-cell receptor T-cell therapies within the same bioreactor. The dataset reported expansion from 10 million peripheral blood mononuclear cells to up to about 9 billion cells within 10 days while maintaining high viability. That illustrates how consolidation can increase predictability while reducing reliance on fragmented, manual workflows.

Consolidation is becoming a design principle, not simply an optimization project. As workflows evolve, the question is becoming whether manufacturing steps are added out of necessity or because a process has not yet been designed and configured for repeatability.