Using Pharmalyte® In Capillary Isoelectric Focusing (cIEF) For Charge Variant Analysis Of Monoclonal Antibodies

By Stephen Lock, Whitney Smith, Marcin Moczulski, and Gerry O’Beirne, Kjell Larsson

The article titled "Using Pharmalyte in Capillary Isoelectric Focusing (cIEF) for Charge Variant Analysis of Monoclonal Antibodies" provides insights into the application of Pharmalyte, a pharmaceutically compliant carrier ampholyte, in capillary isoelectric focusing (cIEF) for the analysis of charge variants in monoclonal antibodies (mAbs). Charge variant analysis of monoclonal antibodies is critical to their characterization, ensuring their safety, efficacy, and stability.

The article explores the benefits of using Pharmalyte in cIEF, which utilizes capillary isoelectric focusing to separate mAbs based on their isoelectric points. Pharmalyte offers advantages such as a broad pH range, good solubility, and low UV absorbance, making it an ideal carrier ampholyte for cIEF. The article presents a case study demonstrating the successful implementation of Pharmalyte in cIEF for charge variant analysis of a mAb, highlighting the resolution and reproducibility achieved.

Additionally, the article discusses the validation of the cIEF method, including system suitability testing, linearity, precision, accuracy, and robustness. These validation parameters ensure the reliability and robustness of the capillary isoelectric focusing (cIEF) analysis for characterizing charge variants in mAbs.

In summary, the article emphasizes the significance of capillary isoelectric focusing (cIEF) and Pharmalyte as a carrier ampholyte in charge variant analysis of monoclonal antibodies. The combination of cIEF and Pharmalyte offers a reliable and effective approach for characterizing and monitoring charge variants, contributing to the overall quality control and development of mAbs.