Masoud Khazaei, Muamer Dervisevic, Nicolas H Voelcker
Cell therapies are increasingly manufactured in closed, automated culture systems, yet decisions about cell quality, safety, and release still rely largely on sparsely executed, destructive, and offline assays. Over the past 5 years, significant progress has been made in developing biosensors capable of real-time measurement of key biochemical and physicochemical indicators including metabolites, ionic species, and protein-associated stress indicators within cell culture environments. However, most systems remain disconnected from manufacturing workflows and fail to support actionable process control. This opinion article discusses the next phase of innovation and the need to reposition biosensors as process analytical technology, shifting the field from descriptive monitoring toward integrated, decision-driven control of cell therapy manufacturing.