Systematic development and optimization of a cIEF method for the charge variants analysis of moderately basic to basic monoclonal antibodies using the Analytical Quality by Design strategy

• A cIEF method for mAbs isoforms profile is proposed • AQbD and mixture design were used for systematic method optimization • Calibration R 2 and pI biases were used as responses for optimization • The cIEF platform successfully profiled five moderately basic to basic mAbs