PRACTICAL MASS SPECTROMETRIC CHARACTERIZATION OF PROTEIN THERAPEUTICS
Slide summary
Instructors:

Guodong Chen Bristol-Myers Squibb	Li Tao Bristol-Myers Squibb	David M. Hambly Amgen

This introductory course is designed for practicing analytical scientists (new users, chromatographers, analytical chemists, protein chemists, and laboratory managers) performing/supporting recombinant protein characterization/analysis, in-process testing, quality control, quality assurance, research and development, and manufacturing.  It covers the fundamental principles and practical applications of mass spectrometry (MS) for the characterization of protein therapeutics with a focus on monoclonal antibodies. It emphasizes problem-solving skills in the areas where MS is used most extensively, for example, characterization of chemical modifications and post-translational modifications of protein therapeutics.  The interpretation of protein therapeutics mass spectra will be illustrated with real case examples.  This course will focus on electrospray ionization (ESI) and matrix-assisted laser desorption / ionization (MALDI) techniques in the analysis of protein therapeutics, and will survey various mass analyzer options for the characterization of protein therapeutics.  A thorough coverage of approaches toward method development for both qualitative and quantitative analysis of protein therapeutics will provide a good starting point for understanding practical issues that are frequently encountered during implementation and applications of MS on protein therapeutics in the laboratory.
Major topics

• Introductions to Protein Therapeutics Mass Spectrometry:  ESI & MALDI for Protein Therapeutics, Mass Spectra of Protein Therapeutics, Peptide Fragmentation
• Commonly Used Mass Analyzers for Analysis of Protein Therapeutics:  Quadrupole, Ion Trap, Time-of-Flight, Orbitrap, Ion Cyclotron Resonance (ICR), Tandem MS (MS/MS)
• MS Method Development for Analysis of Protein Therapeutics:  Intact Mass Analysis, Peptide Mapping, Characterization of Higher Order Structures
• Characterization of Modifications in Protein Therapeutics:  Oxidation, Deamidation / Isomerization, Glycosylation, PEGylation / Conjugation, Unknown Identification
• Quantitative Analysis of Protein Therapeutics:  Sample Preparation, Relative Quantification of Modifications, in vivo Quantification

Prerequisite:   Working knowledge of mass spectrometry and/or protein chemistry