Analysis of Aggregates and Particles in Protein Pharmaceuticals: Mahler/Protein Aggregates Analysis

Content: Chapter 1 The Critical Need for Robust Assays for Quantitation and Characterization of Aggregates of Therapeutic Proteins (pages 1–7): John F. Carpenter, Barry Cherney and Amy S. Rosenberg Chapter 2 Separation?Based Analytical Methods for Measuring Protein Aggregation (pages 9–36): Jun Liu, Barthelemy Demeule and Steven J. Shire Chapter 3 Laser Light Scattering?Based Techniques Used for the Characterization of Protein Therapeutics (pages 37–60): John den Engelsman, Fabian Kebbel and Patrick Garidel Chapter 4 Online Detection Methods and Emerging Techniques for Soluble Aggregates in Protein Pharmaceuticals (pages 61–84): Tapan K. Das Chapter 5 Analytical Methods to Measure Subvisible Particulates (pages 85–115): Shawn Cao, Linda Narhi, Yijia Jiang and Rahul S. Rajan Chapter 6 Detection of Visible Particles in Parenteral Products (pages 117–132): Ronald Smulders, Hans Vos and Hanns?Christian Mahler Chapter 7 Characterization of Aggregates and Particles Using Emerging Techniques (pages 133–167): Hui Zhao, Manuel Diez, Atanas Koulov, Mariola Bozova, Markus Bluemel and Kurt Forrer Chapter 8 Ultraviolet Absorption Spectroscopy (pages 169–200): Reza Esfandiary and Charles Russell Middaugh Chapter 9 Fluorescence Spectroscopy to Characterize Protein Aggregates and Particles (pages 201–226): Robert A. Poole, Andrea Hawe, Wim Jiskoot and Kevin Braeckmans Chapter 10 Infrared Spectroscopy to Characterize Protein Aggregates (pages 227–248): Marco van de Weert and Lene Jorgensen Chapter 11 Raman Microscopy for Characterization of Particles (pages 249–267): Stefan Fischer, Oliver Valet and Markus Lankers Chapter 12 Microscopic Methods for Particle Characterization in Protein Pharmaceuticals (pages 269–302): Patrick Garidel, Andrea Herre and Werner Kliche Chapter 13 Comparison of Methods for Soluble Aggregate Detection and Size Characterization (pages 303–333): John S. Philo Chapter 14 Protein Purification and its Relation to Protein Aggregation and Particles (pages 335–367): Roberto Falkenstein, Stefan Hepbildikler, Wolfgang Kuhne, Thorsten Lemm, Hans Rogl, Eva Rosenberg, Gerhard Winter, Frank Zettl and Ralf Zippelius Chapter 15 Formulation Development and its Relation to Protein Aggregation and Particles (pages 369–387): Miriam Printz and Wolfgang Friess The critical need for robust assays for quantitation and characterization of aggregates of therapeutic proteins Separation based analytical methods for measuring protein aggregation Laser light scattering-based techniques used for the characterization of protein therapeutics Online detection methods and emerging techniques for soluble aggregates in protein pharmaceuticals Analytical methods to measure sub-visible particulates Detection of visible particles in parenteral products Characterization of aggregates and particles using emerging techniques Ultraviolet absorption spectroscopy Fluorescence spectroscopy to characterize protein aggregates and particles Infrared spectroscopy to characterize protein aggregates Raman microscopy for characterization of particles Microscopic methods for particle characterization in protein pharmaceuticals Comparison of methods for soluble aggregate detection and size characterization Protein purification and its relation to protein aggregation and particles Formulation development and its relation to protein aggregation and particles. 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.