The Delights of Diversity: A Multitude of Separation Techniques Combined with Mass Spectrometry for Characterization in Biopharmaceutical Development
Recent years have seen a dramatic increase in the number of separation techniques (e.g. separation based on size, charge, hydrophobicity and affinity) that can be hyphenated to mass spectrometers for in-depth, high-confidence characterization of large and complex biomolecules. This progress has had a profound impact on the way biopharmaceutical characterization is performed during development and how improved product understanding can be obtained more efficiently, with less effort and higher confidence.
The case studies will highlight how different biopharmaceutical development challenges (e.g. poor product stability or undesirable product variants) were addressed effectively using HRAM MS hyphenated to different separation techniques. The case studies will also highlight how data generated by the hyphenated HRAM MS platforms were essential in guiding downstream process development and formulation development to ensure optimal product quality. In short, the hyphenated HRAM MS platforms have become an essential part of the analytical toolbox used for biopharmaceutical development.
Key learning objectives:
- Discussion around the challenges of biotherapeutic analysis due to structural complexity
- Exploration of broad range of chromatographic and other separation techniques
- Analytical strategies to gain more information from a single analysis where an alternative separation technique is coupled to HRAM MS
Who should attend:
- Biopharmaceutical scientists with an interest in characterization by MS, and general analytical development of biopharmaceuticals
- People interested in learning about the role of MS in characterization and QC for biopharmaceuticals
Presenter: Dan Bach Kristensen (Principal Scientist, Symphogen)
Dan Bach Kristensen holds a Ph.D. in biology and B.Sc. degree in chemistry. Dan is specialized in protein chemistry and mass spectrometry, which he initially applied in the field of proteome research in Japan and later in Denmark. For the last 15 years Dan has been working with analytical development in the biopharmaceutical industry, on projects ranging from early discovery through to product registration. Clinical indications include bleeding disorders, neutropenia, autoimmune diseases, and oncology. Dan currently works as a Principal Scientist at Symphogen, which is specialized in the development of antibodies and antibody mixtures for the treatment of cancer.
