Aggregation of Therapeutic Proteins 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.

This book will help in the development of therapeutic proteins, and also instigate further scientific investigations in this area. It provides information on the causes, consequences, characterization, and control of the aggregation of therapeutic proteins.

Contents

1. Fundamental Structures and Behaviors of Proteins
2. Protein Aggregation Pathways, Kinetics, and Thermodynamics
3. Identification and Impact of Aggregation Prone Regions in Proteins and Therapeutic Monoclonal Antibodies
4. External Factors Affecting Protein Aggregation
5. Experimental Detection and Characterization of Protein Aggregates
6. Approaches to Control Protein Aggregation during Bulk Production
7. Protein Aggregation and Particle Formation: Effects of Formulation, Interfaces and Drug Product Manufacturing Operations
8. Approaches to Managing Protein Aggregation in Product Development
9. Case Studies Involving Protein Aggregation
10. Aggregation and Immunogenicity of Therapeutic Proteins
11. Regulatory Perspective on Aggregates as Product Quality Attribute

Index

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