- Patient apheresis heterogeneity from prior systemic therapy, collection settings, anticoagulants, timing, and transport/cryopreservation cannot be “standardized away” and materially impacts identity, potency, and yields.
- Inadequate inclusion of clinically representative starting material during development drives nonrobust parameters, higher GMP batch failure rates, and reactive redesign that delays programs and jeopardizes last-line treatment delivery.
- Read the full article here: PharmTech
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