Bioanalysis Zone

High-resolution mass spectrometry for the quantification of biopharmaceuticals

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LC-MS-based approaches are increasingly used for the quantification of proteins in biological samples. Traditionally, triple quadrupole mass spectrometry (MS/MS) has been the technology of choice; however, a disadvantage of this approach is that severe interferences are sometimes present in the chromatograms originating from peptides of endogenous proteins following sample digestion. In principle, high-resolution mass spectrometry (HRMS) provides increased selectivity due to the ability to select a smaller mass extraction window for quantification. In this presentation, the results of an exploration of HRMS for the quantitative determination of biopharmaceutical proteins and a comparison to nominal mass LC-MS/MS will be provided, including validation results and application to preclinical trials.

What will you learn?

  • Basic immunology
  • Principles of immunogenicity testing
  • Challenges in cut-point determination
  • Immunogenicity of biosimilars

Who may this interest?

People interested in immunology:

  • Scientists
  • Analysts
  • CROs
  • Consultants
  • Quality Managers

Speakers

Arno Kromminga 80x95

Dr. Arno Kromminga
European Chief Strategy Officer
BioAgilytix

Dr. Kromminga is an esteemed senior expert in autoimmunity, allergy, and other immune mediated diseases, including assay development and clinical interpretation of laboratory parameters. He is also a co-founder and board member of the European Immunogenicity Platform (EIP), and member of multiple scientific societies including the American Association of Pharmaceutical Scientists (AAPS), German Society of Immunology (DGfI), German Society of Clinical Chemistry and Laboratory Medicine (DGKL). As a world-leading authority in the area of immunogenicity, he is invited to speak at numerous international scientific conferences and has authored multiple peer-reviewed scientific publications in journals and text books.

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