Analytical Method Development and Characterization Strategies for Monoclonal Antibodies Using UPLC Based Chromatographic and Electrophoretic Techniques

Authors: Jasmine Jinugu

DOI: https://doi.org/10.37082/IJIRMPS.v14.i2.233042

Short DOI: https://doi.org/

Country: United States

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Abstract: Monoclonal antibodies (mAbs) are structurally complex biotherapeutics requiring robust analytical methods to ensure product quality, safety, and efficacy. This work describes the development, optimization, and qualification of multiple analytical techniques—including Size Exclusion Chromatography (SEC UPLC), Cation Exchange Chromatography (CEX UPLC), Isoelectric Focusing (IEF), SDS PAGE, and UV based protein quantification—to support upstream and downstream development activities. Analytical feedback was provided to process teams to guide purification optimization, monitor product heterogeneity, and ensure method suitability for routine characterization. The integration of chromatographic and electrophoretic methods enabled comprehensive assessment of aggregation, charge variants, isoform distribution, purity, and protein concentration. Troubleshooting of UPLC systems ensured consistent performance and minimized analytical downtime. These methods collectively form a robust analytical control strategy aligned with regulatory expectations for mAb development. [1–4,7–8,12]

Keywords: Biopharmaceutical characterization, Electrophoretic techniques, Isoelectric focusing (IEF), SDS‑PAGE, Protein heterogeneity, Stability‑indicating methods, Regulatory analytical strategies, Biologics quality control.

Paper Id: 233042

Published On: 2026-03-10

Published In: Volume 14, Issue 2, March-April 2026

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