The objective of this work is to demonstrate that the BioAccord System can increase confidence and productivity in released glycan analysis for the development of biosimilars.
The SmartMS™-enabled BioAccord System is an easy-to-use LC-MS platform solution that was purposefully designed for comprehensive analysis of biotherapeutic drug products with built-in analytical workflows for specific analysis such as N-Glycan identification and profiling. Within the BioAccord System, highly robust chromatographic separation and accurate mass information can be obtained using the ACQUITY™ UPLC™ I-Class PLUS System and the ACQUITY RDa Detector controlled by UNIFI™ Scientific Information Software. The ACQUITY RDa Detector is a compact bench top time-of-flight mass detector with built-in self-calibration function and straightforward instrument method setup (Figure 1B and 1C), which substantially reduces the complexity of operating MS instruments. Together, high quality LC-FLR and LC-MS data can be acquired and transformed into meaningful results for released glycan analysis using an all-encompassing workflow, reducing the cost and time for biosimilar development without compromising product quality.