Aggregation of Therapeutic Proteins

Author： Wei Wang  

Publisher： John Wiley & Sons Inc‎

Publication year： 2010

E-ISBN: 9780470769812

P-ISBN(Hardback):  9780470411964

Subject： R977.6 protein, saccharide, lipid

Language： ENG

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Description

This book gives pharmaceutical scientists an up-to-date resource on protein aggregation and its consequences, and available methods to control or slow down the aggregation process. While significant progress has been made in the past decade, the current understanding of protein aggregation and its consequences is still immature. Prevention or even moderate inhibition of protein aggregation has been mostly experimental. The knowledge in this book can greatly help pharmaceutical scientists in the development of therapeutic proteins, and also instigate further scientific investigations in this area. This book fills such a need by providing an overview on the causes, consequences, characterization, and control of the aggregation of therapeutic proteins.

Chapter

CONTENTS

pp.：  9 – 19

PREFACE

pp.：  19 – 23

CONTRIBUTORS

pp.：  23 – 25

CHAPTER 1: Fundamental Structures and Behaviors of Proteins

pp.：  25 – 87

CHAPTER 2: Protein Aggregation Pathways, Kinetics, and Thermodynamics

pp.：  87 – 127

CHAPTER 3: Identification and Impact of Aggregation-Prone Regions in Proteins and Therapeutic Monoclonal Antibodies

pp.：  127 – 143

CHAPTER 4: External Factors Affecting Protein Aggregation

pp.：  143 – 229

CHAPTER 5: Experimental Detection and Characterization of Protein Aggregates

pp.：  229 – 281

CHAPTER 6: Approaches to Control Protein Aggregation during Bulk Production

pp.：  281 – 325

CHAPTER 7: Protein Aggregation and Particle Formation: Effects of Formulation, Interfaces, and Drug Product Manufacturing Operations

pp.：  325 – 357

CHAPTER 8: Approaches to Managing Protein Aggregation in Product Development

pp.：  357 – 391

CHAPTER 9: Case Studies Involving Protein Aggregation

pp.：  391 – 427

CHAPTER 10: Aggregation and Immunogenicity of Therapeutic Proteins

pp.：  427 – 459

CHAPTER 11: Regulatory Perspective on Aggregates as a Product Quality Attribute

pp.：  459 – 477

INDEX

pp.：  477 – 511

color plate

pp.：  511 – 514

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