Automating Autologous CAR T Manufacturing: Lessons from Mayo Clinic

Autologous CAR T-cell therapy holds enormous potential, but patient-specific manufacturing introduces persistent challenges around turnaround time, process robustness, quality control, capacity, and technology transfer. In this Cell & Gene Live, Cell & Gene’s Chief Editor, Erin Harris, was joined by Mayo Clinic Center for Regenerative Biotherapeutics’ Snigdha Rai, Senior Director of Biomanufacturing; Anthony DeFusco, MSc, Sr. Director Quality Control; and Cynthia Wilkins, PhD, MS, MBA, Senior Director, Process Development, Assistant Professor of Regenerative Medicine, Mayo Clinic College of Medicine, who shared practical insights from Mayo Clinic’s in-house manufacturing ecosystem. The panel explored how academic centers can work effectively with CDMOs, identify and address production bottlenecks, develop scalable and quality-focused processes, assess alternative manufacturing platforms, and make early CMC decisions that support both clinical execution and long-term commercial readiness.