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Informationen zum Autor HANNS-CHRISTIAN MAHLER is Head of Pharmaceutical and Device Development, Pharma Technical Development Biologics Europe at F. Hoffmann-La Roche Ltd. He is also Lecturer at the Institute for Pharmaceutical Technology at the University of Frankfurt/Main, Germany.WIM JISKOOT is Professor and Head of the Biologics Formulation Group in the Leiden/Amsterdam Center for Drug Research (LACDR) at Leiden University. Klappentext Enables researchers to better detect, measure, and characterize aggregates and particles during protein drug developmentFeaturing contributions from leading pharmaceutical investigators around the world, this text enables researchers to choose the most appropriate analytical methods in order to detect and characterize the full spectrum of protein aggregates and particles that can be present in a protein pharmaceutical. Moreover, the authors provide detailed examples of how these methods can be applied during both process and formulation development, helping researchers better manage the problem of protein instability as they seek to develop protein drugs.The text begins with an introduction to aggregates and particles, focusing on their potential immunogenicity. Next, it covers: Methods to detect and measure soluble aggregates based on separation, light scattering, and new technology Methods to detect and measure insoluble aggregates and both sub-visible and visible particles Spectroscopic techniques such as UV/VIS, fluorescence, infrared and Raman spectroscopy, and microscopy to characterize aggregates and particles, elucidate their structures, and identify proteinaceous and non-proteinaceous particles Comparative advantages and disadvantages of the methods for protein aggregate analysis* Approaches for managing aggregates and particles found during protein purification and formulation developmentThroughout the text, case studies help researchers deal with the challenges that arise in detecting and analyzing protein aggregates and particles.Protein pharmaceuticals are increasingly used to treat life-threatening and chronic diseases, including cancer, viral infections, metabolic disorders, and central nervous system diseases. With Analysis of Aggregates and Particles in Protein Pharmaceuticals as their guide, pharmaceutical researchers now have an important tool in overcoming the challenging problem of aggregates and particles in protein drug development. Zusammenfassung This book describes how to address the analysis of aggregates and particles in protein pharmaceuticals, provides a comprehensive overview of current methods and integrated approaches used to quantify and characterize aggregates and particles, and discusses regulatory requirements. Analytical methods covered in the book include separation, light scattering, microscopy, and spectroscopy. Inhaltsverzeichnis Contributors ixPreface xiiiGlossary xv1 The Critical Need for Robust Assays for Quantitation and Characterization of Aggregates of Therapeutic Proteins 1John F. Carpenter, Barry Cherney, and Amy S. RosenbergI METHODS USED FOR DETECTING, QUANTIFYING, AND SIZING OF PROTEIN AGGREGATES AND PARTICLES 92 Separation-Based Analytical Methods for Measuring Protein Aggregation 11Jun Liu, Barthelemy Demeule, and Steven J. Shire3 Laser Light Scattering-Based Techniques Used for the Characterization of Protein Therapeutics 37John den Engelsman, Fabian Kebbel, and Patrick Garidel4 Online Detection Methods and Emerging Techniques for Soluble Aggregates in Protein Pharmaceuticals 61Tapan K. Das5 Analytical Methods to Measure Subvisible Particulates 85Shawn Cao, Linda Narhi, Yijia Jiang, and Rahul S. Rajan6 Detection of Visible Particles in Parenteral Products 117Ronald Smulders, Hans Vos, and Hanns-Christian Mahler7 Characterization of Aggregates and Particles Using Emerging Techniques 133Hui Zhao, Manuel Diez, Atanas Koulov, Mariola Bozova, Markus Bluemel...
Autorentext
HANNS-CHRISTIAN MAHLER is Head of Pharmaceutical and Device Development, Pharma Technical Development Biologics Europe at F. Hoffmann-La Roche Ltd. He is also Lecturer at the Institute for Pharmaceutical Technology at the University of Frankfurt/Main, Germany. WIM JISKOOT is Professor and Head of the Biologics Formulation Group in the Leiden/Amsterdam Center for Drug Research (LACDR) at Leiden University.
Klappentext
Enables researchers to better detect, measure, and characterize aggregates and particles during protein drug development Featuring contributions from leading pharmaceutical investigators around the world, this text enables researchers to choose the most appropriate analytical methods in order to detect and characterize the full spectrum of protein aggregates and particles that can be present in a protein pharmaceutical. Moreover, the authors provide detailed examples of how these methods can be applied during both process and formulation development, helping researchers better manage the problem of protein instability as they seek to develop protein drugs. The text begins with an introduction to aggregates and particles, focusing on their potential immunogenicity. Next, it covers: Methods to detect and measure soluble aggregates based on separation, light scattering, and new technology Methods to detect and measure insoluble aggregates and both sub-visible and visible particles Spectroscopic techniques such as UV/VIS, fluorescence, infrared and Raman spectroscopy, and microscopy to characterize aggregates and particles, elucidate their structures, and identify proteinaceous and non-proteinaceous particles Comparative advantages and disadvantages of the methods for protein aggregate analysis * Approaches for managing aggregates and particles found during protein purification and formulation development Throughout the text, case studies help researchers deal with the challenges that arise in detecting and analyzing protein aggregates and particles. Protein pharmaceuticals are increasingly used to treat life-threatening and chronic diseases, including cancer, viral infections, metabolic disorders, and central nervous system diseases. With Analysis of Aggregates and Particles in Protein Pharmaceuticals as their guide, pharmaceutical researchers now have an important tool in overcoming the challenging problem of aggregates and particles in protein drug development.
Zusammenfassung
This book describes how to address the analysis of aggregates and particles in protein pharmaceuticals, provides a comprehensive overview of current methods and integrated approaches used to quantify and characterize aggregates and particles, and discusses regulatory requirements. Analytical methods covered in the book include separation, light scattering, microscopy, and spectroscopy.
Inhalt
Contributors ix Preface xiii Glossary xv 1 The Critical Need for Robust Assays for Quantitation and Characterization of Aggregates of Therapeutic Proteins 1 John F. Carpenter, Barry Cherney, and Amy S. Rosenberg I METHODS USED FOR DETECTING, QUANTIFYING, AND SIZING OF PROTEIN AGGREGATES AND PARTICLES 9 2 Separation-Based Analytical Methods for Measuring Protein Aggregation 11 Jun Liu, Barthelemy Demeule, and Steven J. Shire 3 Laser Light Scattering-Based Techniques Used for the Characterization of Protein Therapeutics 37 John den Engelsman, Fabian Kebbel, and Patrick Garidel 4 Online Detection Methods and Emerging Techniques for Soluble Aggregates in Protein Pharmaceuticals 61 Tapan K. Das 5 Analytical Methods to Measure Subvisible Particulates 85 Shawn Cao, Linda Narhi, Yijia Jiang, and Rahul S. Rajan 6 Detection of Visible Particles in Parenteral Products 117 Ronald Smulders, Hans Vos, and Hanns-Christian Mahler 7 Characterization of Aggregates and Particles Using Emerging Techniques 133 Hui Zhao, Manuel Diez, Atanas Koulov, Mariola Bozova, Markus Bluemel, and Kurt Forrer II METHODS USED TO CHARACTERIZE PROTEIN AGGREGATES AND PARTICLES 169 8 Ultraviolet Absor…