Rapid monitoring of CQAs for therapeutic mAbs is a critical need to support the rapid growth in the commercial and clinical mAb pipeline. Until recently, there has not been a single analytical tool that could provide rapid, quantitative, and high-resolution charge variant analysis along with the molecular mass identification of peaks. The Blaze system provides a single characterization method to enable iCIEF-MS analysis of mAbs, all in a 15-minute assay1.
We will demonstrate the unique capability of the Blaze iCIEF system to directly identify cIEF-separated peaks by mass spectrometry of adalumimab, a therapeutic antibody. The Blaze analysis was interfaced with the TripleTOF® 6600+ Quadrupole Time-Of-Flight (QTOF) from SCIEX and data was analyzed using a new Blaze iCIEF-MS workflow in Protein Metrics Byos® software, developed specifically for the Blaze data. Advancements in method development will be described that enabled the identification of glycation, succinimide intermediates, unprocessed C-terminal lysine, and the N-glycan profile for each of these identified proteoforms, as well as other late breaking results.
1Mack, S., et al. (2019). Electrophoresis, 40(23-24), 3084-3091