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A CAR-T therapy is a personalized manufacturing process: the patients own T cells are extracted via leukapheresis, transduced with a viral vector carrying the chimeric antigen receptor (CAR) construct, expanded in bioreactors under specific culture conditions, formulated, and re-infused

Lilly argued that the added ingredients (B12, glycine) were cosmetic differentiators rather than meaningful clinical modifications, and that the pharmacies were essentially circumventing the end of the shortage declaration

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