RAPID HPLC-MS/MS EVALUATION OF THE BATCH-TO-BATCH CONSISTENCY OF THE PAYLOADS SUBSTITUTION OF A LYSINE ANTIBODY-DRUG-CONJUGATES (ADCS)

摘要

The aim of this work is the determination of the drug substitution sites of a lysine antibody-drug conjugate (ADC) by a very specific LC-MS analysis of its peptide digests [1][2]. Conjugated peptides were detected with high sensitivity and specificity by monitoring the characteristic reporter fragment ions of the cytotoxic molecule. Moreover, the batch-to-batch consistency of the conjugation was studied to evaluate the reproducibility of the production process.