High throughput capillary electrophoresis analysis of biopharmaceuticals utilizing sequential injections.

The complexity of biotherapeutic products implies an ever-increasing list of product quality attributes that need to be monitored and characterized. In addition, the growing interest in implementing process analytical technology (PAT) in biopharmaceutical production has further increased the testing burden, together with the need for rapid testing that can facilitate real-time or near-real time decision making. Capillary electrophoresis (CE) has made a place in biopharmaceutical analysis but is regarded as a low throughput method, with the instrument dead time constituting more than 80% of the total time of analysis. In this study, the dead time of CE was utilized to analyse 3 mAb samples in a single CE run. This approach resulted in an up to 77% reduction in the total analysis time and increased the productivity by up to 300%, compared to traditional single CE-UV runs, without compromising resolution or relative peak areas. Additionally, good method reproducibility was observed. The compatibility of the method has been demonstrated with protein A eluate, and cation exchange chromatography fractions. We thus propose that sequential injections can be applied for fast and robust CE analysis of biopharmaceuticals. This article is protected by copyright. All rights reserved.