Release, Redefined: QC Testing Across In Vivo And Ex Vivo CAR-T

CAR-T development is moving along two connected paths: established ex vivo manufacturing, where patient or donor cells are engineered outside the body, and emerging in vivo approaches that aim to perform that engineering directly within the patient. Lentiviral vectors play an important role in both models, but each creates different demands for drug product quality control. Identity, potency, sterility, and safety assays must support reliable release decisions while adapting to the speed, scale, and complexity of the chosen manufacturing strategy. Gain a clearer view of how QC expectations shift across ex vivo and in vivo CAR-T workflows, and explore a practical framework designed to make ex vivo release testing faster, more consistent, and better aligned with the needs of expanding patient access.