MEASUREMENT OF INTACT MASS OF PROTEIN-CONJUGATED AGENT COMPOUNDS

摘要

To provide methods and systems for rapid measurement of the intact mass of non-covalently bonded antibody heavy chains (HC) and light chains (LC) which result from bonding of drug conjugates to interchain cysteine residues.SOLUTION: By analyzing an antibody-drug conjugate (ADC) under native desalting conditions, an intact-bivalent structure of the ADC, which ordinarily may decompose as a consequence of denaturing chromatographic conditions typically used for LCMS, is maintained. The mass of the desalted ADC is subsequently determined using desolvation and ionization ESI-MS conditions. The methods described herein provide direct measurement of the intact mass of an ADC conjugated at interchain cysteine residues. The methods described herein also provide the relative quantitation of individual ADC species.SELECTED DRAWING: Figure 1