In recent years, the multi-attribute method (MAM) has become an important mass spectrometry-based tool for identifying and quantifying the site-specific product attributes and purity information for biotherapeutics such as monoclonal antibodies (mAbs) and fusion molecules. As the multi-attribute method becomes more widely used in drug development, it is important to improve the throughput of sample preparation without introducing chemical modifications and variability.

In the following publication we discuss the development of a fully automated MAM sample preparation protocol that incorporates rapid desalting (< 15 min) using miniaturised size-exclusion chromatography columns in pipette tips on an automated liquid handling system leading to complete digestion of mAbs in approximately 3 hours with excellent reproducibility

  • sample analysis using electrospray ionisation mass spectrometry coupled to a U-HPLC system with dual column switching
  • a comparison of the new sample preparation method with manual low artefact sample preparation including analysis of recovery, reproducibility, efficiency and flexibility

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