Validating Protein Concentration of Antibody-Drug Conjugates with the CTechTM SoloVPE® System

Abstract

Antibody-drug conjugates (ADCs) are complex molecules designed to target and kill tumor cells. ADCs consist of a monoclonal antibody, drug linker, and drug (payload), where the antibody generally targets the protein on the tumor cell. UV-Vis spectroscopy is the simplest and most common method to determine protein concentration of ADCs; however, traditional fixed-pathlength spectrophotometers have issues analyzing these complex molecules. The CTechTM SoloVPE® System variable pathlength method, also known as the Slope Spectroscopy® method, offers a more accurate solution. This publication demonstrates how an assay by the SoloVPE method was validated to determine the protein concentration of an ADC. The method was validated by assessing the precision, accuracy, and linearity of the sample. The SoloVPE passed all acceptance criteria seamlessly, proving the technology to be the superior method for this application.