Aggregation of Therapeutic Proteins
Herausgegeben von Wang, Wei; Roberts, Christopher J.
Aggregation of Therapeutic Proteins
Herausgegeben von Wang, Wei; Roberts, Christopher J.
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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…mehr
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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.
Produktdetails
- Produktdetails
- Verlag: Wiley & Sons
- 1. Auflage
- Seitenzahl: 512
- Erscheinungstermin: 30. August 2010
- Englisch
- Abmessung: 251mm x 167mm x 30mm
- Gewicht: 826g
- ISBN-13: 9780470411964
- ISBN-10: 0470411961
- Artikelnr.: 29931233
- Verlag: Wiley & Sons
- 1. Auflage
- Seitenzahl: 512
- Erscheinungstermin: 30. August 2010
- Englisch
- Abmessung: 251mm x 167mm x 30mm
- Gewicht: 826g
- ISBN-13: 9780470411964
- ISBN-10: 0470411961
- Artikelnr.: 29931233
WEI WANG, PhD, is a Research Fellow at Pfizer Global Biologics. He is also Adjunct Professor in the School of Pharmacy and Health at the University of the Pacific in California and Guest Professor at Shandong University in China. CHRISTOPHER J. ROBERTS, PhD, is Associate Professor of Chemical Engineering at the University of Delaware. Previously, he was a senior research scientist in pharmaceutical R & D at Pfizer.
Chapter 1. Fundamental Structures and Behaviors of Proteins (Jennifer S.
Laurence and C. Russell Middaugh). 1.1 The Problem of Protein Aggregation.
1.2 Parallels to Protein Folding. 1.3 Views of Protein Stability and
Aggregation. 1.4 Models of Aggregation. 1.5 Models of Protein Folding. 1.6
Influences of Chemical Alteration on Aggregation. 1.7 Approaches to
Predicting Aggregation. 1.8 Conclusions. 1.9 References. Chapter 2. Protein
Aggregation Pathways, Kinetics, and Thermodynamics (Yi Li and Christopher
J. Roberts). 2.1 Introduction. 2.2 Native and Non-Native Aggregation
Pathway(s). 2.3 Thermodynamics of Reversible Self-Association. 2.4
Aggregation Kinetics and Distinguishing Kinetic Pathways. 2.5 Chemical
Modifications. 2.6 Effects of Cosolvents or Cosolutes. 2.7 Nomenclature.
2.8 Appendix - Derivation of "32 for a van der Waals Mixture. 2.9
Acknowledgements. 2.10 References. Chapter 3. Identification and Impact of
Aggregation Prone Regions in Proteins and Therapeutic Monoclonal Antibodies
(Sandeep Kumar, Xiaoling Wang, and Satish K. Singh). 3.1 Introduction. 3.2
Energy Landscapes, Protein Folding and Aggregation. 3.3 Prediction of
Aggregation Prone Regions in Proteins and Biotherapeutics. 3.4 Conclusions
and Future Directions. 3.5 Acknowledgments . 3.6 Abbreviations. 3.7
References. Chapter 4. External Factors Affecting Protein Aggregation (Wei
Wang, Ning Li, and Stan Speaker). 4.1 Introduction. 4.2 Protein Aggregation
Pathways. 4.3 Effects of Temperature. 4.4 Effects of Solution Conditions
and Composition on Protein Aggregation. 4.5 Effects of Processing Steps on
Protein Aggregation. 4.6 Effects of Solid-State Conditions and Composition
on Protein Aggregation. 4.7 Summary. 4.8 Acknowledgements. 4.9 References.
Chapter 5. Experimental Detection and Characterization of Protein
Aggregates (Vikas K. Sharma and Devendra S. Kalonia). 5.1 Introduction. 5.2
Aggregate Classification. 5.3 Analytical Tools for Characterization of
Aggregates. 5.4 Summary. 5.5 References. Chapter 6. Approaches to Control
Protein Aggregation during Bulk Production (Linda O. Narhi, Yijia Jiang,
Rohini Deshpande, Sohye Kang, and Joseph Shultz). 6.1 Introduction. 6.2
Candidate selection. 6.3 Protein aggregation and cell culture. 6.4 Protein
aggregation and purification. 6.5 Summary. 6.6 References. Chapter 7.
Protein Aggregation and Particle Formation: Effects of Formulation,
Interfaces and Drug Product Manufacturing Operations (Hanns-Christian
Mahler, Stefan Fischer, Theodore W. Randolph, and John F. Carpenter). 7.1
Introduction. 7.2 Roles of Conformational and Colloidal Stability in
Reducing Rates of Aggregation. 7.3 Effects of Interfaces on Protein
Aggregation. 7.4 Critical processing steps during drug product
manufacturing of biopharmaceuticals. 7.5 Particles in parenteral products
and visible inspection. 7.6 Summary and Outlook. 7.7 References. Chapter 8.
Approaches to Managing Protein Aggregation in Product Development (Wei Wang
and Nicholas W. Warne). 8.1 Introduction. 8.2 Approaches in Formulation
Development. 8.3 Protection of Proteins in Various Processing Steps. 8.4
Aggregation Control by Structural Modifications. 8.5 Summary. 8.6
References. Chapter 9. Case Studies Involving Protein Aggregation (Rahul S.
Rajan, Tiansheng Li, and Tsutomu Arakawa). 9.1 Introduction. 9.2 Case study
1. Aggregation in the liquid state: the role of osmolytes in stabilizing
Keratinocyte Growth Factor (KGF) towards aggregation. 9.3 Case Study 2:
Aggregation in the liquid state: heterogeneity and non-linearity in IgG2
aggregation during long term storage. 9.4 Case Study 3: Aggregation in the
frozen state: the role of excipient crystallization. 9.5. Case Studies 4&5:
Aggregation in the lyophilized state: role of residual moisture and
mechanisms of excipient stabilization. 9.6 Case study 6: Protein
particulation due to nucleation by foreign material in fill/finish
manufacturing operations. 9.7 Overall Discussion. 9.8 Acknowledgements. 9.9
References. Chapter 10. Aggregation and Immunogenicity of Therapeutic
Proteins (Vasco Filipe, Andrea Hawe, Huub Schellekens, and Wim Jiskoot).
10.1 Introduction. 10.2 Immunogenicity of therapeutic proteins. 10.3 Immune
mechanisms related to protein immunogenicity. 10.4 Aggregates and
Immunogenicity. 10.5 Conclusions. 10.6 References. Chapter 11. Regulatory
Perspective on Aggregates as Product Quality Attribute (Wendy C. Weinberg,
Linan Ha, Susan L. Kirshner, and Daniela I. Verthelyi). 11.1 Introduction.
11.2 An overview of the regulatory process. 11.3 Product aggregates and
safety concerns. 11.4 The assessment of aggregates: regulatory approaches
to controlling product aggregation. 11.5 Future challenges. 11.6 Summary.
11.7 Acknowledgements. 11.8 References.
Laurence and C. Russell Middaugh). 1.1 The Problem of Protein Aggregation.
1.2 Parallels to Protein Folding. 1.3 Views of Protein Stability and
Aggregation. 1.4 Models of Aggregation. 1.5 Models of Protein Folding. 1.6
Influences of Chemical Alteration on Aggregation. 1.7 Approaches to
Predicting Aggregation. 1.8 Conclusions. 1.9 References. Chapter 2. Protein
Aggregation Pathways, Kinetics, and Thermodynamics (Yi Li and Christopher
J. Roberts). 2.1 Introduction. 2.2 Native and Non-Native Aggregation
Pathway(s). 2.3 Thermodynamics of Reversible Self-Association. 2.4
Aggregation Kinetics and Distinguishing Kinetic Pathways. 2.5 Chemical
Modifications. 2.6 Effects of Cosolvents or Cosolutes. 2.7 Nomenclature.
2.8 Appendix - Derivation of "32 for a van der Waals Mixture. 2.9
Acknowledgements. 2.10 References. Chapter 3. Identification and Impact of
Aggregation Prone Regions in Proteins and Therapeutic Monoclonal Antibodies
(Sandeep Kumar, Xiaoling Wang, and Satish K. Singh). 3.1 Introduction. 3.2
Energy Landscapes, Protein Folding and Aggregation. 3.3 Prediction of
Aggregation Prone Regions in Proteins and Biotherapeutics. 3.4 Conclusions
and Future Directions. 3.5 Acknowledgments . 3.6 Abbreviations. 3.7
References. Chapter 4. External Factors Affecting Protein Aggregation (Wei
Wang, Ning Li, and Stan Speaker). 4.1 Introduction. 4.2 Protein Aggregation
Pathways. 4.3 Effects of Temperature. 4.4 Effects of Solution Conditions
and Composition on Protein Aggregation. 4.5 Effects of Processing Steps on
Protein Aggregation. 4.6 Effects of Solid-State Conditions and Composition
on Protein Aggregation. 4.7 Summary. 4.8 Acknowledgements. 4.9 References.
Chapter 5. Experimental Detection and Characterization of Protein
Aggregates (Vikas K. Sharma and Devendra S. Kalonia). 5.1 Introduction. 5.2
Aggregate Classification. 5.3 Analytical Tools for Characterization of
Aggregates. 5.4 Summary. 5.5 References. Chapter 6. Approaches to Control
Protein Aggregation during Bulk Production (Linda O. Narhi, Yijia Jiang,
Rohini Deshpande, Sohye Kang, and Joseph Shultz). 6.1 Introduction. 6.2
Candidate selection. 6.3 Protein aggregation and cell culture. 6.4 Protein
aggregation and purification. 6.5 Summary. 6.6 References. Chapter 7.
Protein Aggregation and Particle Formation: Effects of Formulation,
Interfaces and Drug Product Manufacturing Operations (Hanns-Christian
Mahler, Stefan Fischer, Theodore W. Randolph, and John F. Carpenter). 7.1
Introduction. 7.2 Roles of Conformational and Colloidal Stability in
Reducing Rates of Aggregation. 7.3 Effects of Interfaces on Protein
Aggregation. 7.4 Critical processing steps during drug product
manufacturing of biopharmaceuticals. 7.5 Particles in parenteral products
and visible inspection. 7.6 Summary and Outlook. 7.7 References. Chapter 8.
Approaches to Managing Protein Aggregation in Product Development (Wei Wang
and Nicholas W. Warne). 8.1 Introduction. 8.2 Approaches in Formulation
Development. 8.3 Protection of Proteins in Various Processing Steps. 8.4
Aggregation Control by Structural Modifications. 8.5 Summary. 8.6
References. Chapter 9. Case Studies Involving Protein Aggregation (Rahul S.
Rajan, Tiansheng Li, and Tsutomu Arakawa). 9.1 Introduction. 9.2 Case study
1. Aggregation in the liquid state: the role of osmolytes in stabilizing
Keratinocyte Growth Factor (KGF) towards aggregation. 9.3 Case Study 2:
Aggregation in the liquid state: heterogeneity and non-linearity in IgG2
aggregation during long term storage. 9.4 Case Study 3: Aggregation in the
frozen state: the role of excipient crystallization. 9.5. Case Studies 4&5:
Aggregation in the lyophilized state: role of residual moisture and
mechanisms of excipient stabilization. 9.6 Case study 6: Protein
particulation due to nucleation by foreign material in fill/finish
manufacturing operations. 9.7 Overall Discussion. 9.8 Acknowledgements. 9.9
References. Chapter 10. Aggregation and Immunogenicity of Therapeutic
Proteins (Vasco Filipe, Andrea Hawe, Huub Schellekens, and Wim Jiskoot).
10.1 Introduction. 10.2 Immunogenicity of therapeutic proteins. 10.3 Immune
mechanisms related to protein immunogenicity. 10.4 Aggregates and
Immunogenicity. 10.5 Conclusions. 10.6 References. Chapter 11. Regulatory
Perspective on Aggregates as Product Quality Attribute (Wendy C. Weinberg,
Linan Ha, Susan L. Kirshner, and Daniela I. Verthelyi). 11.1 Introduction.
11.2 An overview of the regulatory process. 11.3 Product aggregates and
safety concerns. 11.4 The assessment of aggregates: regulatory approaches
to controlling product aggregation. 11.5 Future challenges. 11.6 Summary.
11.7 Acknowledgements. 11.8 References.
Chapter 1. Fundamental Structures and Behaviors of Proteins (Jennifer S.
Laurence and C. Russell Middaugh). 1.1 The Problem of Protein Aggregation.
1.2 Parallels to Protein Folding. 1.3 Views of Protein Stability and
Aggregation. 1.4 Models of Aggregation. 1.5 Models of Protein Folding. 1.6
Influences of Chemical Alteration on Aggregation. 1.7 Approaches to
Predicting Aggregation. 1.8 Conclusions. 1.9 References. Chapter 2. Protein
Aggregation Pathways, Kinetics, and Thermodynamics (Yi Li and Christopher
J. Roberts). 2.1 Introduction. 2.2 Native and Non-Native Aggregation
Pathway(s). 2.3 Thermodynamics of Reversible Self-Association. 2.4
Aggregation Kinetics and Distinguishing Kinetic Pathways. 2.5 Chemical
Modifications. 2.6 Effects of Cosolvents or Cosolutes. 2.7 Nomenclature.
2.8 Appendix - Derivation of "32 for a van der Waals Mixture. 2.9
Acknowledgements. 2.10 References. Chapter 3. Identification and Impact of
Aggregation Prone Regions in Proteins and Therapeutic Monoclonal Antibodies
(Sandeep Kumar, Xiaoling Wang, and Satish K. Singh). 3.1 Introduction. 3.2
Energy Landscapes, Protein Folding and Aggregation. 3.3 Prediction of
Aggregation Prone Regions in Proteins and Biotherapeutics. 3.4 Conclusions
and Future Directions. 3.5 Acknowledgments . 3.6 Abbreviations. 3.7
References. Chapter 4. External Factors Affecting Protein Aggregation (Wei
Wang, Ning Li, and Stan Speaker). 4.1 Introduction. 4.2 Protein Aggregation
Pathways. 4.3 Effects of Temperature. 4.4 Effects of Solution Conditions
and Composition on Protein Aggregation. 4.5 Effects of Processing Steps on
Protein Aggregation. 4.6 Effects of Solid-State Conditions and Composition
on Protein Aggregation. 4.7 Summary. 4.8 Acknowledgements. 4.9 References.
Chapter 5. Experimental Detection and Characterization of Protein
Aggregates (Vikas K. Sharma and Devendra S. Kalonia). 5.1 Introduction. 5.2
Aggregate Classification. 5.3 Analytical Tools for Characterization of
Aggregates. 5.4 Summary. 5.5 References. Chapter 6. Approaches to Control
Protein Aggregation during Bulk Production (Linda O. Narhi, Yijia Jiang,
Rohini Deshpande, Sohye Kang, and Joseph Shultz). 6.1 Introduction. 6.2
Candidate selection. 6.3 Protein aggregation and cell culture. 6.4 Protein
aggregation and purification. 6.5 Summary. 6.6 References. Chapter 7.
Protein Aggregation and Particle Formation: Effects of Formulation,
Interfaces and Drug Product Manufacturing Operations (Hanns-Christian
Mahler, Stefan Fischer, Theodore W. Randolph, and John F. Carpenter). 7.1
Introduction. 7.2 Roles of Conformational and Colloidal Stability in
Reducing Rates of Aggregation. 7.3 Effects of Interfaces on Protein
Aggregation. 7.4 Critical processing steps during drug product
manufacturing of biopharmaceuticals. 7.5 Particles in parenteral products
and visible inspection. 7.6 Summary and Outlook. 7.7 References. Chapter 8.
Approaches to Managing Protein Aggregation in Product Development (Wei Wang
and Nicholas W. Warne). 8.1 Introduction. 8.2 Approaches in Formulation
Development. 8.3 Protection of Proteins in Various Processing Steps. 8.4
Aggregation Control by Structural Modifications. 8.5 Summary. 8.6
References. Chapter 9. Case Studies Involving Protein Aggregation (Rahul S.
Rajan, Tiansheng Li, and Tsutomu Arakawa). 9.1 Introduction. 9.2 Case study
1. Aggregation in the liquid state: the role of osmolytes in stabilizing
Keratinocyte Growth Factor (KGF) towards aggregation. 9.3 Case Study 2:
Aggregation in the liquid state: heterogeneity and non-linearity in IgG2
aggregation during long term storage. 9.4 Case Study 3: Aggregation in the
frozen state: the role of excipient crystallization. 9.5. Case Studies 4&5:
Aggregation in the lyophilized state: role of residual moisture and
mechanisms of excipient stabilization. 9.6 Case study 6: Protein
particulation due to nucleation by foreign material in fill/finish
manufacturing operations. 9.7 Overall Discussion. 9.8 Acknowledgements. 9.9
References. Chapter 10. Aggregation and Immunogenicity of Therapeutic
Proteins (Vasco Filipe, Andrea Hawe, Huub Schellekens, and Wim Jiskoot).
10.1 Introduction. 10.2 Immunogenicity of therapeutic proteins. 10.3 Immune
mechanisms related to protein immunogenicity. 10.4 Aggregates and
Immunogenicity. 10.5 Conclusions. 10.6 References. Chapter 11. Regulatory
Perspective on Aggregates as Product Quality Attribute (Wendy C. Weinberg,
Linan Ha, Susan L. Kirshner, and Daniela I. Verthelyi). 11.1 Introduction.
11.2 An overview of the regulatory process. 11.3 Product aggregates and
safety concerns. 11.4 The assessment of aggregates: regulatory approaches
to controlling product aggregation. 11.5 Future challenges. 11.6 Summary.
11.7 Acknowledgements. 11.8 References.
Laurence and C. Russell Middaugh). 1.1 The Problem of Protein Aggregation.
1.2 Parallels to Protein Folding. 1.3 Views of Protein Stability and
Aggregation. 1.4 Models of Aggregation. 1.5 Models of Protein Folding. 1.6
Influences of Chemical Alteration on Aggregation. 1.7 Approaches to
Predicting Aggregation. 1.8 Conclusions. 1.9 References. Chapter 2. Protein
Aggregation Pathways, Kinetics, and Thermodynamics (Yi Li and Christopher
J. Roberts). 2.1 Introduction. 2.2 Native and Non-Native Aggregation
Pathway(s). 2.3 Thermodynamics of Reversible Self-Association. 2.4
Aggregation Kinetics and Distinguishing Kinetic Pathways. 2.5 Chemical
Modifications. 2.6 Effects of Cosolvents or Cosolutes. 2.7 Nomenclature.
2.8 Appendix - Derivation of "32 for a van der Waals Mixture. 2.9
Acknowledgements. 2.10 References. Chapter 3. Identification and Impact of
Aggregation Prone Regions in Proteins and Therapeutic Monoclonal Antibodies
(Sandeep Kumar, Xiaoling Wang, and Satish K. Singh). 3.1 Introduction. 3.2
Energy Landscapes, Protein Folding and Aggregation. 3.3 Prediction of
Aggregation Prone Regions in Proteins and Biotherapeutics. 3.4 Conclusions
and Future Directions. 3.5 Acknowledgments . 3.6 Abbreviations. 3.7
References. Chapter 4. External Factors Affecting Protein Aggregation (Wei
Wang, Ning Li, and Stan Speaker). 4.1 Introduction. 4.2 Protein Aggregation
Pathways. 4.3 Effects of Temperature. 4.4 Effects of Solution Conditions
and Composition on Protein Aggregation. 4.5 Effects of Processing Steps on
Protein Aggregation. 4.6 Effects of Solid-State Conditions and Composition
on Protein Aggregation. 4.7 Summary. 4.8 Acknowledgements. 4.9 References.
Chapter 5. Experimental Detection and Characterization of Protein
Aggregates (Vikas K. Sharma and Devendra S. Kalonia). 5.1 Introduction. 5.2
Aggregate Classification. 5.3 Analytical Tools for Characterization of
Aggregates. 5.4 Summary. 5.5 References. Chapter 6. Approaches to Control
Protein Aggregation during Bulk Production (Linda O. Narhi, Yijia Jiang,
Rohini Deshpande, Sohye Kang, and Joseph Shultz). 6.1 Introduction. 6.2
Candidate selection. 6.3 Protein aggregation and cell culture. 6.4 Protein
aggregation and purification. 6.5 Summary. 6.6 References. Chapter 7.
Protein Aggregation and Particle Formation: Effects of Formulation,
Interfaces and Drug Product Manufacturing Operations (Hanns-Christian
Mahler, Stefan Fischer, Theodore W. Randolph, and John F. Carpenter). 7.1
Introduction. 7.2 Roles of Conformational and Colloidal Stability in
Reducing Rates of Aggregation. 7.3 Effects of Interfaces on Protein
Aggregation. 7.4 Critical processing steps during drug product
manufacturing of biopharmaceuticals. 7.5 Particles in parenteral products
and visible inspection. 7.6 Summary and Outlook. 7.7 References. Chapter 8.
Approaches to Managing Protein Aggregation in Product Development (Wei Wang
and Nicholas W. Warne). 8.1 Introduction. 8.2 Approaches in Formulation
Development. 8.3 Protection of Proteins in Various Processing Steps. 8.4
Aggregation Control by Structural Modifications. 8.5 Summary. 8.6
References. Chapter 9. Case Studies Involving Protein Aggregation (Rahul S.
Rajan, Tiansheng Li, and Tsutomu Arakawa). 9.1 Introduction. 9.2 Case study
1. Aggregation in the liquid state: the role of osmolytes in stabilizing
Keratinocyte Growth Factor (KGF) towards aggregation. 9.3 Case Study 2:
Aggregation in the liquid state: heterogeneity and non-linearity in IgG2
aggregation during long term storage. 9.4 Case Study 3: Aggregation in the
frozen state: the role of excipient crystallization. 9.5. Case Studies 4&5:
Aggregation in the lyophilized state: role of residual moisture and
mechanisms of excipient stabilization. 9.6 Case study 6: Protein
particulation due to nucleation by foreign material in fill/finish
manufacturing operations. 9.7 Overall Discussion. 9.8 Acknowledgements. 9.9
References. Chapter 10. Aggregation and Immunogenicity of Therapeutic
Proteins (Vasco Filipe, Andrea Hawe, Huub Schellekens, and Wim Jiskoot).
10.1 Introduction. 10.2 Immunogenicity of therapeutic proteins. 10.3 Immune
mechanisms related to protein immunogenicity. 10.4 Aggregates and
Immunogenicity. 10.5 Conclusions. 10.6 References. Chapter 11. Regulatory
Perspective on Aggregates as Product Quality Attribute (Wendy C. Weinberg,
Linan Ha, Susan L. Kirshner, and Daniela I. Verthelyi). 11.1 Introduction.
11.2 An overview of the regulatory process. 11.3 Product aggregates and
safety concerns. 11.4 The assessment of aggregates: regulatory approaches
to controlling product aggregation. 11.5 Future challenges. 11.6 Summary.
11.7 Acknowledgements. 11.8 References.