Revolutionizing Biotherapeutic Analysis: Novel icIEF Fractionation and Mass Spectrometry for Charge Characterization

1. The use of novel imaged capillary isoelectric focusing (icIEF) fractionation and mass spectrometry (MS) techniques has revolutionized the analysis of biotherapeutics, providing a more comprehensive understanding of their charge characteristics.
2. icIEF fractionation is a high-resolution protein separation technique that allows for the separation of proteins based on their isoelectric point (pI), which is the pH at which a protein carries no net electrical charge.
3. Mass spectrometry is a powerful analytical technique used to determine the mass-to-charge ratio of ions, which can provide detailed information about the structure and composition of proteins.
4. The combination of icIEF fractionation and MS allows for the precise characterization of charge variants in biotherapeutics, which is crucial for ensuring the safety, efficacy, and consistency of these complex molecules.
5. Charge variants in biotherapeutics can arise due to various factors, including post-translational modifications, deamidation, oxidation, and glycosylation, and can significantly impact their biological activity and stability.
6. The use of icIEF fractionation and MS for charge characterization of biotherapeutics is becoming increasingly important in the biopharmaceutical industry, as it can help to streamline the development and manufacturing processes, reduce costs, and improve product quality.
7. This novel approach to protein analysis has the potential to significantly advance the field of biotherapeutics, enabling the development of more effective and targeted treatments for a wide range of diseases.