Utilizing novel icIEF fractionation and mass spec for the charge characterization of biotherapeutics
Imaged capillary isoelectric focusing (icIEF) has emerged as the preferred method for protein charge profiling. Lan Li, Senior Principal Scientist at Amgen, provides insights into the need for charge variant analysis, sharing her evaluation of the MauriceFlex technology for fractionations in the context of charge variant analysis of monoclonal antibodies. She discusses her initial analytical method assessment to determine if it is fit for purpose, fractionation evaluation and outcome, general feedback on the technology, and recommendations based on her overall experience. Amreen Jonas, Principal Associate Scientist at Mersana Therapeutics, demonstrates the use of the MauriceFlex™ instrument to fractionate a monoclonal antibody (mAb) using icIEF followed by intact mass spec analysis, enabling the accurate identification of distinct isoforms, and providing insights into the mAb’s charge heterogeneity. The MauriceFlex instrument is a novel platform that integrates icIEF, CE-SDS analysis, and protein charge isoform fractionation into one unit, enabling users to go beyond routine charge and size and perform charge variant analysis of their molecule at any point without requiring the use of separate techniques like IEX and HPLC.
- How to characterize protein charge heterogenity
- How to gain novel insights in protein characterization by combining icIEF with mass spec analysis
- How to develop a simplified and flexible workflow to improve protein characterization
