CAR-T's $500K Quality Problem: Why the Most Expensive Therapy in Medicine Still Relies on Manual Flow Cytometry

CAR-T cell therapy costs $500K per dose with a 30-day manufacturing bottleneck. Flow cytometry QC — still largely manual — is the rate-limiting step. As next-day manufacturing emerges, AI-automated analysis isn't optional. It's existential. We trace the evidence from 7 FDA-approved products, a $6B market, and 600+ clinical trials to show why the first company to deliver AI-automated high-dimensional flow cytometry QC will own the quality infrastructure of a $45B industry.