AI and digital transformation in cell and gene therapy: enabling scalable and predictable biomanufacturing

Cell and gene therapy (CGT) has demonstrated transformative clinical potential; however, challenges in scalability, cost, and process consistency continue to limit widespread adoption. AI and digital transformation are emerging as critical enablers to address these bottlenecks. From predictive vector design to smart manufacturing and real-time quality control, AI-driven approaches are reshaping the CGT lifecycle. This article explores how integrated digital ecosystems, advanced analytics, and automation accelerate CGT industrialization while highlighting key implementation challenges and regulatory considerations.