Abstract
Disitamab vedotin (RC48), a humanized anti-HER2 antibody conjugated with monomethyl auristatin E (MMAE), is the first antibody-drug conjugate in China with an approved biological license application. A bioanalytical method was established for three analytes (total antibody, conjugate antibody and free payload) to help characterize their pharmacokinetic behavior in clinical settings. The bioanalytical methods were validated according to M10 guidance. Electrochemiluminescence assaymethods were used for thequantitative measurement of total antibody and conjugated antibody in human serum. A LC-MS/MSmethod was used to quantify the concentration of MMAE in human serum. The method had high specificity and sensitivity with a quantitative range of 19.531-1250.000ng/ml (total antibody), 39.063-5000.000ng/ml (conjugated antibody)and 0.04-10.0ng/ml (MMAE), respectively.
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