Measurement of ADC stability in serum via subunit DAR analysis

Stability of biologics is a critical quality attribute (CQA)affecting the levels of dosing and efficacy. Measurement of this can be complicated by the inherent heterogeneity present within the protein in addition to linker and payloads of ADCs. Mass Spectrometry (MS) is an appealing technique for these measurements as loss of payload can be measured on the protein level or as a released drug. Intact measurements have the benefit of minimising sample handling after incubation compared to enzymatic release methods.

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