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An Automated MS Data Workflow Enabling Targeted, Site-Specific Glycosylation Monitoring of Biopharmaceuticals

Glycosylations are Critical Quality Attributes (CQAs) whose modulation during upstream processes is challenging but essential. For example, fine-tuning of sialylation is key to achieving optimal bioavailability and limiting adverse immune reactions. Current biopharmaceutical industry trends—including increasingly complex fusion proteins and higher throughputs—are revealing significant limitations in conventional released glycan analyses such as 2AB-UPLC and CGE-LIF.

Discover how scientists at Merck overcame these limitations by implementing an automated MS-based glycopeptide mapping workflow for monitoring glycosylation. Compared to conventional released-glycan analysis methods, the advantages of this workflow include:

  • The ability to monitor glycosylation at the site-specific, amino-acid level instead of just at the global level
  • Higher confidence in automated peak assignment through accurate mass measurement, making co-elution issues a thing of the past
  • User-friendly processing of 45 samples in under an hour, instead of the several days of expert manual review that would otherwise be required.
Key Learning Objectives
  • Learn about the advantages of MS-based methods over conventional released-glycan analysis methods
  • Discover how automating MS-data processing and analysis dramatically increases productivity while reducing operator-related variability.
  • Pauline Ulrich, Pharm.D., Associate Scientist, Biotech Process Sciences Analytics, Merck, Corsier-sur-Vevey, Switzerland
  • Diego Bertaccini, Ph.D., Senior Scientist, Biotech Process Sciences Analytics, Merck, Corsier-sur-Vevey, Switzerland
Who Should Watch

Biopharma analytical scientists and managers who are looking to automate mass spectrometry-based analytical workflows for characterization and quality monitoring of biotherapeutics.

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