Liquid chromatography-mass spectrometry (LC-MS) is a vital tool for analytical characterization and bioprocess development support. However there are two critical bottlenecks to its implementation into the respective workflows: the complexity of the crude bioprocess samples and the perceived difficulty in mastering the LC-MS analysis. We address these two questions in this two-part seminar. In the first part, we present a streamlined LC-MS platform that serves two critical purposes for bioprocesses: biosimilar comparative assessment and bioprocess analytical development. In the second part, we pivot the very same LC-MS platform to monitoring critical quality attributes (CQA) of sgRNA and mRNA for product quality and process consistency, and how these MS-based RNA analysis is made accessible to biologics experts.

• Simplified LC-MS acquisition using BioAccord™ LC-MS System, a benchtop TOF MS designed for ease of operation for analysts of all levels of expertise
• Utilization of the waters_connect™ Intact Mass App for streamlined automated data acquisition and analysis with compliance-ready features to ensure data integrity
• Automated ProA purification for biosimilar subunit analysis
• Biosimilar CQAs analysis (Fab vs Fc modifications, orthogonality between mab subunit workflow and released N-glycan assays)
• RNA CQAs analysis (sgRNA, mRNA and RNA digest fragment mapping)

LC-MS

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