Increasing Productivity and Confidence for N-linked Glycan Analysis of Biosimilars Using the BioAccord System

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Ximo Zhang, Corey Reed, Henry Shion, William Alley, Robert Birdsall, and Ying Qing Yu
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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.

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