Analysis of Aggregates and Particles in Protein Pharmaceuticals

Analysis of Aggregates and Particles in Protein Pharmaceuticals

By: Hanns-Christian Mahler (editor), Wim Jiskoot (editor)Hardback

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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.

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About Author

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.


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 Absorption Spectroscopy 171 Reza Esfandiary and Charles Russell Middaugh 9 Fluorescence Spectroscopy to Characterize Protein Aggregates and Particles 201 Robert A. Poole, Andrea Hawe, Wim Jiskoot, and Kevin Braeckmans 10 Infrared Spectroscopy to Characterize Protein Aggregates 227 Marco van de Weert and Lene Jorgensen 11 Raman Microscopy for Characterization of Particles 249 Stefan Fischer, Oliver Valet, and Markus Lankers 12 Microscopic Methods for Particle Characterization in Protein Pharmaceuticals 269 Patrick Garidel, Andrea Herre, and Werner Kliche III INTEGRATED APPROACHES TO PROTEIN AGGREGATION AND PARTICLES 303 13 Comparison of Methods for Soluble Aggregate Detection and Size Characterization 305 John S. Philo 14 Protein Purification and Its Relation to Protein Aggregation and Particles 335 Roberto Falkenstein, Stefan Hepbildikler, Wolfgang Kuhne, Thorsten Lemm, Hans Rogl, Eva Rosenberg, Gerhard Winter, Frank Zettl, and Ralf Zippelius 15 Formulation Development and Its Relation to Protein Aggregation and Particles 369 Miriam Printz and Wolfgang Friess Index 389

Product Details

  • publication date: 22/10/2010
  • ISBN13: 9780470497180
  • Format: Hardback
  • Number Of Pages: 464
  • ID: 9780470497180
  • weight: 786
  • ISBN10: 0470497181

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