Upstream Quality Control of Therapeutic Antibodies using Automated IdeS Digestion and Subunit Separation in Combination with Ultrahigh-Resolution QTOF Analysis

摘要

This automated sample preparation technique can be used to easily and rapidly prepare Fc- and F(ab')2-fractions of an antibody, ready for high resolution LC-MS analysis. The analysis of those fractions enables the measurement of important quality attributes such as the primary sequence correctness, the presence of free cysteines and the detailed glycoprofile of the conserved N-glycan on the F_C. The ease of preparation and analysis allows these measurements to take place early in the development process to ensure an optimal clone selection and understanding of the design space.