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

Lucrezia Floris; Benedetta Pasquini; Serena Orlandini; Francesca Luciani; Gabriella Massolini; Sandra Furlanetto; Roberto Gotti

doi:10.1016/j.jpba.2026.117576

May 1, 2026Journal of Pharmaceutical and Biomedical AnalysisOpen Access

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

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Key Points

This research aims to develop and optimize a cIEF method for analyzing charge variants of moderately basic to basic monoclonal antibodies.
Developed a capillary isoelectric focusing (cIEF) method for profiling mAbs' isoforms.
Utilized Analytical Quality by Design (AQbD) and mixture design for systematic optimization.
Assessed calibration R² and pI biases as responses for method optimization.
Successfully profiled five moderately basic to basic monoclonal antibodies using cIEF.
Achieved high calibration R² values indicating robustness of the method.
Minimized pI biases during optimization, enhancing accuracy of analysis.

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Implication

Demonstrates charge variants analysis of monoclonal antibodies, suggesting an effective method for evaluation.

Abstract

• 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

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Floris et al. (2026) studied this question.

synapsesocial.com/papers/6a13e8520e02ee3982d3300d https://doi.org/10.1016/j.jpba.2026.117576

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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

Key Points

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Implication

Abstract

Discussion

Cite This Study

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

Key Points

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Implication

Abstract

Discussion

Cite This Study

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