Capillary Electrophoresis in Biotherapeutic Development: Platform Methods, Fragment Workflows, and ADC Characterization
Precise, reproducible, and regulatory-ready: CE-based methods are redefining how scientists characterize therapeutic mAbs and ADCs across the biotherapeutic development pipeline.
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This Expert Insights eBook hopes to provide scientists with more information on capillary electrophoresis (CE)-based methods for the analytical characterization of therapeutic monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs), allowing you to further your research in biotherapeutic development, manufacturing, and regulatory submission.
What you will learn about:
- Platform-ready CE methods (CZE and iCIEF) for charge variant analysis across diverse mAb formats, including bispecifics with pI values spanning 6 to 10
- A systematic four-pathway workflow for identifying and characterizing product-related fragments detected by CE-SDS, without dedicated enrichment or chromatographic purification
- Multilevel ADC characterization using icIEF-UV/MS and EAD peptide mapping to confirm drug-antibody ratio (DAR), site-specific payload attachment, and key post-translational modifications
- Enhanced detection sensitivity and reproducibility using native fluorescence detection (NFD) and the latest ZenoTOF 8600 system for trace-level PQA characterization
Capillary Electrophoresis in Biotherapeutic Development
Download this complimentary Expert Insights eBook today!More Information
Therapeutic monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) are among the most powerful tools in modern medicine, offering high target specificity and, in the case of ADCs, the ability to deliver cytotoxic payloads directly to diseased cells. However, their inherent molecular complexity, spanning charge heterogeneity, post-translational modifications, fragmentation, and conjugation variability, presents substantial analytical challenges throughout development, manufacturing, and regulatory submission. Capillary electrophoresis (CE)-based techniques are particularly valuable in this context, offering rapid, high-resolution separations based on fundamental physicochemical properties, such as size, charge, and isoelectric point. This Expert Insights eBook highlights recent advances in CE methodology and its application to two critical quality dimensions of biotherapeutics: charge variant profiling and fragment characterization, culminating in a demonstration of how CE and mass spectrometry can be integrated for comprehensive ADC characterization.
