Charge variants analysis of biotherapeutics by fully automated Capillary Isoelectric Focusing (cIEF) and High Res Mass Spectrometry

Monitoring of biologics charge variants (one of the major CQA’s) is constant requirement during all stage of mAb therapeutics development and manufacturing and QC release test. In addition, as there are an increasing number of biosimilars coming into the marketplace, charge heterogeneity differences between these biosimilars and their innovator counterparts also generate the need for thorough charge variants analysis, in order to support process development and regulatory submission.

Traditionally off-line fractionation by ion exchange chromatography, with subsequent mass spectrometry analysis, has also been applied in many mAb charge variants analysis.

CE and CE-MS is an orthogonal technique to IEX LC/MS for charge variant profiling. CE separation can be directly connected mass spectrometry for on-line analysis of change variants, and it can detect subtle protein variations that would be missed by other technologies.

Presenter: Dr. James Xia (CEO & Principal Scientist, CMP Scientific Corp)

Presenter: Ms. Sreelakshmy Menon (Application Scientist, Agilent Technologies)