Charge heterogeneity is present in most biopharmaceutical protein products. For antibody-drug conjugates (ADCs) the antibody, the linker, and the payload all contribute to the heterogeneity, which adds complexity to the charge variant profiles. Isolation and identification of charge variants is important in product characterization and manufacturing control strategy development.
Capillary isoelectric focusing (cIEF) is a popular technique for monitoring protein charge heterogeneity. However, direct peak identification from electropherograms often requires extensive lab work, including orthogonal LC method development, fractionation, offline MS characterization, and multiple cIEF re-analysis.
This webinar discusses the evaluation of a novel integrated icIEF-UV/MS system to identify and monitor the charged modifications on the ADC payloads in near real-time and disentangle the contribution of the payload from the antibody modifications.
- Reduce charge heterogeneity analysis workflow from weeks to minutes.
- Elucidate critical post-translational modifications (PTMs), including glycosylation, deamidation, and payload modifications.
- Enable mass characterization of charge variants and payload modifications of intact ADCs.
- Monitor charged modifications on ADC payload in near real-time with the Intabio ZT system.