Designing CGT Manufacturing for Scale, Speed, and Access

As cell and gene therapies continue to deliver promising clinical results, manufacturing remains one of the biggest barriers to broader commercialization. Persistent challenges around cost, complexity, labor intensity, and vein-to-vein timelines—particularly for autologous CAR-T therapies—are limiting the industry’s ability to scale beyond niche and last-line indications. Addressing these constraints will be critical if CGTs are to move earlier in treatment paradigms and reach more patients globally.

In this episode of Off Script, we spoke with Jon Ellis, CEO of Trenchant BioSystems, about the current state of cell and gene therapy manufacturing and where the industry must go next. The conversation explores why traditional centralized manufacturing models are struggling to scale, how automation and digital batch records can significantly compress manufacturing timelines, and how emerging platforms are rethinking cell recovery, analytics integration, and starting material strategies.