Manufacturing requirements are killing cell and gene therapy.

Manufacturing requirements are killing cell and gene therapy. Ruxandra Teslo argues that for CAR-T, paperwork-level thresholds and noisy tests can block drugs that still work, and turn manufacturing into the real bottleneck. “Legend Biotech’s leadership later calculated that if those stricter commercial standards had been applied retroactively to the original trial data, the out-of-specification rate would have risen from 2 percent to 18 percent.” ~ learn more