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General information
Location: Gripsholmsviken Hotell & Konferens, Mariefred, Sweden ->
Early registration: up to 2 months before the start of the course Standard registration: up to 1 month before the start of the course Late registration: less than 1 month before the start of the course Lecturers: Dr. Sven Jacobsson and Dr. Jan Ståhlberg
Who should take this course? The course is designed for those that work with the analysis of proteins in quality control and assurance or in research and development. Attendees should preferably have a university degree in chemistry, pharmaceutics, biology or related fields. Course schedule Day 1 - Introductory discussion about the role of analysis and characterization of proteins with particular focus on biopharmaceuticals - Equilibrium in a chromatographic column and the retention factor - Band broadenings mechanisms in a chromatographic column - Resolution - Gradient chromatography - Review of thermodynamic concepts Day 2 - Intermolecular interactions and the hydrophobic effect - The primary, secondary and tertiary structures of proteins - The chemical properties of proteins such as deamidation, oxidation, glycosylation - The physical properties of proteins; charge, aggregation, denaturation - Adsorption of proteins to surfaces - Overview of techniques used to characterize and analyze proteins (UV. Fluorescence, NMR, CZE, etc. Day 3 Principles of chromatographic techniques used to analyze and characterize proteins: - Ion Exchange Chromatography - Size Exclusion Chromatography - Reversed Phase Chromatography - Affinity Chromatography - Hydrophobic Interaction Chromatography - Overview of Mass Spectrometry - LC/MS in the analysis and characterization of proteins. Operating parameters and characteristics Day 4 - Proteins as therapeutic drugs - Overview of the ICH guidelines for biotechnological products with focus on ICH Q5 C and E - Quality aspects of protein drugs and how this is monitored and tested - Identification and monitoring of common protein modifications - How to make a specification of a protein substance and which tests to use - How to make a specification of a formulated protein therapeutic drug and which tests to use - Tests and methods that are stability indicating - How to perform a comparability study when changing the production process or when developing biosimilars
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