Over the past decade we have witnessed the growth in biotherapeutic drugs, with this expansion expected to accelerate in the coming years. The vast majority of these biotherapeutics, especially therapeutic antibodies, are glycosylated. Glycosylation is one of the most common protein post-translational modifications and due to the enormous diversity in glycosylation structure, patterns and attachment this leads to multiple glycoprotein isoforms. Small differences in the glycosylation of the biotherapeutic can have dramatic effects on the drug's efficacy and safety and as such for any biotherapeutic there are strict requirements for the oligosaccharide content of glycoprotein drugs to be fully characterised, measured and mapped to ensure product consistency.
In this webinar, Dr. Ken Cook will briefly overview the current regulatory requirements surrounding the use of glycoproteins as biotherapeutics. The current, most commonly employed, separation and detection technologies for the major categories of glycan analysis will be discussed with a particular focus on the use of UHPLC and Mass Spectrometry based techniques. A more detailed description of the critical elements required from a UHPLC based separation and Mass Spectrometry based detection for glycoprotein analysis will conclude this section. Practical examples of glycosylation analysis will be presented by Prof. Dr. Christian Huber, showing the use of high-performance liquid chromatography and high-resolution mass spectrometry to be able to precisely determine glycosylation patterns and relative glycan quantities of therapeutic antibodies on the basis of intact molecule mass measurements.
Register today to learn more about the rapid evolving regulatory and technological advances related to glycoprotein biopharmaceuticals, current methodologies and the technological requirements to be able to conduct glycan analysis in an efficient, reproducible and cost-effective manner. Learn how scientists are using these tools today.
Dr. Ken Cook,
EU Bio-Separations Support Expert, Thermo Fisher Scientific
Dr. Cook has over 20 years experience supporting liquid and ion chromatography applications with Dionex initially and then Thermo Fisher Scientific. Dr. Cook currently supports customers with bio-separations, focusing on biotherapeutics. Prior to Dionex and Thermo Fisher Scientific, Dr. Cook was a marketing manager for capillary electrophoresis at Prince Technologies. Previously Dr. Cook was a lecturer in Biochemistry at the University of Newcastle-Upon-Tyne, UK
Dr. Christian Huber,
Professor of Chemistry for Biosciences, University of Salzburg
Dr. Huber has performed research in the area of protein separations and their characterization by mass spectrometry for more than 20 years. He developed and employed polymer-based particular and monolithic stationary phases for high-resolution protein separations. Currently, his group focuses on biological mass spectrometry with emphasis on the characterization of post-translational modifications at the intact protein level. He is head of the Christian Doppler Laboratory for Innovative Tools for Biosimilar Characterizarion established in collaboration with Sandoz Biopharmaceuticals, Thermo Fisher Scientific, and the Christian Doppler Society. (www.cdg.ac.at)
- Glycosylation of biotherapeutics, effects on efficacy and safety and regulatory requirements
- Current (U)HPLC separation and Mass Spectrometry detection technologies for the characterisation of glycoproteins
- What are the critical requirements from both (U)HPLC and Mass Spectrometry for effective glycan analysis
- How modern separation and detection tools are uncovering glycoprotein structures and its relevance to today's biopharmaceutical development
- R&D
- Lab Managers
- Principal Investigators
- C Level Management
- Scientist
- Core Facility Directors
- Biopharma Applications
- Biopharma Development and Production
- Product Quality
- Quality Control
