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Each batch is intended to be supported by identity confirmation and chromatographic profiling, along with clear reporting of method conditions and acceptance thresholds so data can be interpreted consistently across instruments and operators

Notably, dosing interals (intermittent vs continuous) influence both therapeutic efficacy and adverse events such as thrombocytopenia

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The principal engineering upgrade of this strategy lies in its superior specificity and stoichiometric occupancy

While such approaches are promising, systematic immuno-safety assessment frameworks remain limited, and predictive models for patient-specific immune responses are urgently needed

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