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During biotherapeutic development, it is necessary to monitor properties of the therapeutic molecule and formulation that have been identified as critical quality attributes (CQAs) for product safety and efficacy. Currently, these analyses are conducted using optical detection. More recently, there is a trend among leading biopharmaceutical organizations to incorporate mass spectrometry into these routine assays, largely due to bimolecular complexity, but also as a means to assess more attributes in fewer analyses.

In particular, the industry is seeking to monitor post-translational modifications (PTMs), glycosylation profiles, and excipients with both UV and mass data by implementing multi-analyte or so-called Multi Attribute Methods (MAMs). These MAM assays are typically targeted toward monitoring downstream processes, but they are increasingly looked at as QC assays for lot release.

Incorporating MAMs into these environments requires the availability of analytical technologies that can be easily deployed and managed in GMP environments. Mass spectrometry, however, can require highly trained personnel and significant lab infrastructure—but recently this landscape has started to change. In this webinar, we will discuss the benefits of utilizing a cost-effective, compact, and user-friendly mass detector for routine monitoring of multiple biotherapeutic attributes. We will demonstrate through application examples that combining UV and mass detection delivers the orthogonal data points that can enable the direct and efficient implementation of MAM assays.

Who Should Attend

  • Biopharmaceutical development scientists
  • Biopharmaceutical lab mangers responsible for technology adoption and lab efficiency programs
  • QC/QA analysts
  • Analytical scientists interested in glycan and peptide analysis

You Will Learn

  • How mass detection can provide the necessary specificity and sensitivity during routine monitoring of protein PTMs and identity testing when used as a supplement to optical workflows.
  • About the unique design and capabilities of the ACQUITY® QDa® Detector, as well as its ability to be deployed in compliant-ready environments that use Empower 3 Software.
  • How the ACQUITY QDa Detector revolutionizes monitoring of released N-Glycan profiles when used with RapiFluor-MS™, a new rapid labeling technology.
  • About applications of the ACQUITY QDa Detector beyond peptide and glycan analysis.

Produced with support from:

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Sean M. McCarthy, Ph.D.
Senior Manager
Waters Corporation