Increasing the Throughput of CE-SDS Experiments for the Determination of Purity in Biotherapeutic Products – A Bridging Case Study

Capillary electrophoresis sodium dodecyl sulfate (CE-SDS) is a workhorse method for the characterization of purity and impurities attributes of biotherapeutic products. In this study, we compared the performance, throughput, and precision of two instruments manufactured by Sciex: the newly developed BioPhase 8800 and the classical PA800+. Four different monoclonal antibodies, anonymized as mAb A-D, were analyzed under reducing and non-reducing conditions and with manual and automated sample preparation on both instruments. In addition, a design of experiment (DoE) study was carried out to fully exploit the high throughput capabilities of the BioPhase 8800. Results demonstrate that data generated on the BioPhase 8800 were highly comparable to those obtained on the PA800+ instrument and that high precision was easily achievable with both manual and automated sample preparation. Moreover, because the throughput of the BioPhase 8800 is 8-fold higher than that of the PA800+, screening and DoE studies become a mainstream application of CE-SDS experiments.