ENGLISH

Aggregation of Therapeutic Proteins

Book information

Year
2010
ISBN
9780470411964, 9780470769829
DOI
10.1002/9780470769829
Language
english
Format
PDF
Filesize
9 MB (9288783 bytes)
Pages
502\502
Orientation
yes
Scanned
yes
Time added
2013-08-01 04:00:00

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.Content: Chapter 1 Fundamental Structures and Behaviors of Proteins (pages 1–61): Jennifer S. Laurence and C. Russell MiddaughChapter 2 Protein Aggregation Pathways, Kinetics, and Thermodynamics (pages 63–102): Yi Li and Christopher J. RobertsChapter 3 Identification and Impact of Aggregation?Prone Regions in Proteins and Therapeutic Monoclonal Antibodies (pages 103–118): Sandeep Kumar, Xiaoling Wang and Satish K. SinghChapter 4 External Factors Affecting Protein Aggregation (pages 119–204): Wei Wang, Ning Li and Stan SpeakerChapter 5 Experimental Detection and Characterization of Protein Aggregates (pages 205–256): Vikas K. Sharma and Devendra S. KaloniaChapter 6 Approaches to Control Protein Aggregation during Bulk Production (pages 257–299): Linda O. Narhi, Yijia Jiang, Rohini Deshpande, Sohye Kang and Joseph ShultzChapter 7 Protein Aggregation and Particle Formation: Effects of Formulation, Interfaces, and Drug Product Manufacturing Operations (pages 301–331): Hanns?Christian Mahler, Stefan Fischer, Theodore W. Randolph and John F. CarpenterChapter 8 Approaches to Managing Protein Aggregation in Product Development (pages 333–365): Wei Wang and Nicholas W. WarneChapter 9 Case Studies Involving Protein Aggregation (pages 367–401): Rahul S. Rajan, Tiansheng Li and Tsutomu ArakawaChapter 10 Aggregation and Immunogenicity of Therapeutic Proteins (pages 403–433): Vasco Filipe, Andrea Hawe, Huub Schellekens and Wim JiskootChapter 11 Regulatory Perspective on Aggregates as a Product Quality Attribute (pages 435–451): Wendy C. Weinberg, Linan Ha, Susan L. Kirshner and Daniela I. Verthelyi

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