Analysis of Aggregates and Particles in Protein Pharmaceuticals

Copyright © 2012 John Wiley & Sons, Inc.

Analysis of Aggregates and Particles in Protein Pharmaceuticals

Editor(s): Hanns-Christian Mahler, Wim Jiskoot

Published Online: 13 JAN 2012 09:53AM EST

Print ISBN: 9780470497180

Online ISBN: 9781118150573

DOI: 10.1002/9781118150573

About this Book

Product Information

About The Product

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.

Table of contents

    1. You have free access to this content
      Frontmatter (pages i–xvi)

    1. You have free access to this content
      Color Plates (pages c1–c12)

    1. 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

  4. Section I: Methods Used for Detecting, Quantifying, and Sizing of Protein Aggregates and Particles

    1. Chapter 2

      Separation-Based Analytical Methods for Measuring Protein Aggregation (pages 9–36)

      Jun Liu, Barthélemy Demeule and Steven J. Shire

    2. 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

    3. Chapter 4

      Online Detection Methods and Emerging Techniques for Soluble Aggregates in Protein Pharmaceuticals (pages 61–84)

      Tapan K. Das

    4. Chapter 5

      Analytical Methods to Measure Subvisible Particulates (pages 85–115)

      Shawn Cao, Linda Narhi, Yijia Jiang and Rahul S. Rajan

    5. Chapter 6

      Detection of Visible Particles in Parenteral Products (pages 117–132)

      Ronald Smulders, Hans Vos and Hanns-Christian Mahler

    6. 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

  5. Section II: Methods Used to Characterize Protein Aggregates and Particles

    1. Chapter 8

      Ultraviolet Absorption Spectroscopy (pages 169–200)

      Reza Esfandiary and Charles Russell Middaugh

    2. Chapter 9

      Fluorescence Spectroscopy to Characterize Protein Aggregates and Particles (pages 201–226)

      Robert A. Poole, Andrea Hawe, Wim Jiskoot and Kevin Braeckmans

    3. Chapter 10

      Infrared Spectroscopy to Characterize Protein Aggregates (pages 227–248)

      Marco van de Weert and Lene Jørgensen

    4. Chapter 11

      Raman Microscopy for Characterization of Particles (pages 249–267)

      Stefan Fischer, Oliver Valet and Markus Lankers

    5. Chapter 12

      Microscopic Methods for Particle Characterization in Protein Pharmaceuticals (pages 269–302)

      Patrick Garidel, Andrea Herre and Werner Kliche

  6. Section III: Integrated Approaches to Protein Aggregation and Particles

    1. Chapter 13

      Comparison of Methods for Soluble Aggregate Detection and Size Characterization (pages 303–333)

      John S. Philo

    2. 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

    3. Chapter 15

      Formulation Development and its Relation to Protein Aggregation and Particles (pages 369–387)

      Miriam Printz and Wolfgang Friess

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      Index (pages 389–443)

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