This volume describes novel and emerging analytical technologies for analysis of proteins with the emphasis on technologies aimed to address characterization knowledge gaps and/or improve our ability to measure specified attributes with improved selectivity, sensitivity, resolution, and throughput.Higher order structure of proteins is a recognized important attribute of mAbs, with potential implications on stability, safety, and biological function of these large molecules. This book, the last in a series of three volumes, touches on topics ranging from X-ray crystallography, NMR, hydrogen-deuterium exchange mass spectrometry, covalent labeling techniques, and ion mobility mass spectrometry.
1. Trends and Drivers for the Development of Next-Generation Biotherapeutic Characterization Tools; 2. Emerging Technologies To Assess the Higher Order Structure of Monoclonal Antibodies; 3. Covalent Labeling Techniques for Characterizing Higher Order Structure of Monoclonal Antibodies; 4. Ion Mobility and Mass Spectrometry Measurements of the Humanized; 5. Characterization of Monoclonal Antibody Aggregates and Emerging Technologies; 6. Simultaneous Multiple Sample Light Scattering (SMSLS) for Continuous Monitoring of Protein Aggregation; 7. Informatics for Mass Spectrometry-Based Protein Characterization; 8. Adventitious Agent Testing of Biologicals:: Changing to a New Frontier of Technology, Cell-Based to Nucleic Acid-Based Detection; 9. Monoclonal Antibody Analysis Using Microfluidic Technologies; 10. Intact Antibody Characterization Using Orbitrap Mass Spectrometry; 11. Rapid Middle-Down Sequence Determination of Antibodies by MALDI In-Source Decay MS; 12. Automated, Online Sample Preparation for LC-MS Analyses:: Affinity Capture, Digestion, and Clean-Up; 13. Improved Identification and Quantification of Host Cell Proteins (HCPs) in Biotherapeutics Using Liquid Chromatography-Mass Spectrometry; 14. Towards a Comprehensive Bioinformatic Analysis of the NIST Reference mAb; 15. A Global Partnership Advancing Biopharmaceutical Development:: Summary and Future Perspectives;
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