Rational design of stable protein formulations: theory and practice
Saved in:
| Format: | Book |
|---|---|
| Language: | English |
| Published: |
New York
Kluwer Academic
2002
|
| Series: | Pharmaceutical biotechnology
13 |
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Item Description: | Includes bibliographical references and index |
| Physical Description: | XVII, 203 S. Ill., graph. Darst. : 24 cm |
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MARC
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| 245 | 1 | 0 | |a Rational design of stable protein formulations |b theory and practice |c ed. by John F. Carpenter and Mark C. Manning |
| 264 | 1 | |a New York |b Kluwer Academic |c 2002 | |
| 300 | |a XVII, 203 S. |b Ill., graph. Darst. : 24 cm | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 490 | 1 | |a Pharmaceutical biotechnology |v 13 | |
| 500 | |a Includes bibliographical references and index | ||
| 650 | 4 | |a Médicaments - Conception | |
| 650 | 4 | |a Médicaments protéiques - Stabilité | |
| 650 | 4 | |a Technologie des protéines | |
| 650 | 4 | |a Drug Design | |
| 650 | 4 | |a Drug Stability | |
| 650 | 4 | |a Drugs |x Design | |
| 650 | 4 | |a Protein Engineering | |
| 650 | 4 | |a Protein drugs |x Stability | |
| 650 | 4 | |a Protein engineering | |
| 700 | 1 | |a Carpenter, John F. |e Sonstige |4 oth | |
| 700 | 1 | |a Manning, Mark C. |e Sonstige |4 oth | |
| 830 | 0 | |a Pharmaceutical biotechnology |v 13 |w (DE-604)BV007730074 |9 13 | |
| 856 | 4 | 2 | |m HBZ Datenaustausch |q application/pdf |u http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009883671&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |3 Inhaltsverzeichnis |
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Record in the Search Index
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| adam_text | Contents
Chapter 1
Practical Approaches to Protein Formulation Development
Byeong S. Chang and Susan Hershenson
Introduction 1
Preparation for Formulation Development 3
Resource Requirements for Formulation Development 3
Useful Information for Designing Formulations 4
Preformulation Development 4
Characterization of Protein Pharmaceuticals 5
Accelerated Stability Studies 5
Development of Analytical Methods 6
Evaluation of the Significance of Problems 7
Formulation Development 10
Formulation Options for Protein Pharmaceuticals 10
Typical Protein Stability Problems: Causes and Solutions 13
Optimization of Formulation Variables 13
Necessary Studies for Formulation Development 15
Strategies to Overcome Difficult Formulation Problems 17
Formulation in Commercial Product Development 18
Critical Formulation Decisions During Pharmaceutical
Development 18
Formulation for Early Preclinical and Clinical Studies 19
Commercial Formulation 19
Regulatory Issues in Formulation Development 20
xiii
Appendix: List of Regulatory Documents 22
References 23
Chapter 2
Recombinant Production of Native Proteins from Escherichia coli
Tsutomu Arakawa, Jiansheng Li, and Linda O. Narhi
Introduction 27
Distribution of Expressed Proteins 28
Cell Washing and Lysis 32
Purification of Soluble, Folded Proteins 34
Purification and Refolding of Soluble, Misfolded Proteins 35
Purification and Refolding of Proteins from Inclusion Bodies 36
Washing and Solubilization of Inclusion Bodies 36
Purification of Expressed Proteins from Inclusion Bodies 36
Refolding Mechanism 38
Disulfide Bond Formation 41
Removal of Denaturant 41
Effects of Tag Sequences 44
Effects of Excipients 44
Response Surface Methodology 47
High Pressure Disaggregation and Refolding 48
Methods to Analyze Folded Structures 48
Bioactivity 49
Binding to Receptors 49
Dilsulfide Bond Analysis 50
Spectroscopy 50
Conformational Stability 51
Limited Proteolysis 51
References 51
Chapter 3
Physical Stabilization of Proteins in Aqueous Solution
Brent S. Kendrick, Jiansheng Li, and Byeong S. Chang
Introduction 61
Overview of Physical Stability 62
Thermodynamic Control of Protein Stability 62
Kinetic Control of Protein Stability 63
Interactions of Excipients with Proteins 65
Preferentially Excluded Cosolvents 66
Buffers/Salts 67
Specific Binding of Ligands 68
Protein Self Stabilization 69
Physical Factors Affecting Protein Stability 70
Temperature 70
Freeze Thawing 71
Agitation and Exposure to Denaturing Interfaces 71
Pressure 72
Conclusions 73
Appendix: Derivation of the Wyman Linkage Function and
Application to the Timasheff Preferential Exclusion
Mechanism 73
References 78
Chapter 4
Effects of Conformation on the Chemical Stability of Pharmaceutically
Relevant Polypeptides
Jeffrey D. Meyer, Bert Ho, and Mark C. Manning
Introduction 85
Relationship Between Structure and Deamidation Rates 86
Primary Structure Effects 87
Secondary Structure Effects 89
Tertiary Structure Effects 91
Summary of Structure Effects on Deamidation 92
Role of Structure in Protein Oxidation 92
Types of Oxidation Processes 93
Effects of Oxidation of Surface and Buried Methionines on
Protein Structure 95
Limiting Solvent Accessibility of Residues 96
Conformational Control of Oxidation in Aqueous Solution 97
Structural Control of Oxidation in Lyophilized Products 99
Summary of Structural Control of Oxidation 100
Summary 101
References 101
Chapter 5
Rational Design of Stable Lyophilized Protein Formulations:
Theory and Practice
John F. Carpenter, Beyong S. Chang, William Garzon Rodriguez, and
Theodore W. Randolph
Introduction 109
Minimal Criteria for a Successful Lyophilized Formulation Ill
Inhibition of Lyophilization Induced Protein Unfolding 112
Storage at Temperatures Below Formulation Glass Transition
Temperature 113
The Water Content is Relatively Low 114
A Strong, Elegant Cake Structure is Obtained 114
Steps Taken to Minimize Specific Routes of Protein Chemical
Degradation 116
Rational Design of Stable Lyophiilized Formulations 117
Choice of Buffer 118
Specific Ligands/pH that Optimizes Thermodynamic Stability of
Protein 119
Trehalose or Sucrose to Inhibit Protein Unfolding and Provide
Glassy Matrix 120
Bulking Agent (e.g., Mannitol, Glycine or Hydroxyethyl Starch) .... 126
Nonionic Surfactant to Inhibit Aggregation 127
Acknowledgments 127
References 127
Chapter 6
Spray Drying of Proteins
Geoffrey Lee
Introduction: Why Spray Dry a Protein? 135
Developments in the Last 10 Years 136
The Practice of Spray Drying Proteins 139
Type of Equipment 139
Spray Drying Conditions 140
Influence of Formulation 147
Pure Proteins 147
Formulated Systems 149
Use of Added Surface Active Substances 151
Concluding Remarks 156
References 156
Chapter 7
Surfactant Protein Interactions
Theodore W. Randolph and LaToya S. Jones
Introduction 159
Proteins and Surfactants at Surfaces 161
Protein Surfactant Interactions in Solution 166
Surfactant Effects on Protein Assembly State 167
Surfactant Effects on Proteins During Freezing, Freeze Drying
and Reconstitution 169
Enzymatic Degradation of Non Ionic Surfactants 170
Recommendations for Protein Formulation 170
References 171
Chapter 8
High Throughput Formulation: Strategies for Rapid Development of
Stable Protein Products
Rajiv Nayar and Mark C. Manning
Introduction 177
Overall Structure of the HTF Approach 179
Role of an Established Decision Tree for Formulation Design 181
Constraints on a Pharmaceutically Acceptable Protein
Formulation 182
Proper Choice of Dosage Form 183
Preformulation Studies 185
Proper Choice of Excipients 186
Estimates of Resources Needed for Formulation Development 188
Use of Software and Databases to Assist in the HTF Process 189
Essential Analytical Methods 191
Stability Protocols 193
Unified Strategy for HTF 194
References 195
Index 199
|
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| indexdate | 2024-07-09T19:03:08Z |
| institution | BVB |
| language | English |
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| owner_facet | DE-19 DE-BY-UBM DE-526 DE-11 |
| physical | XVII, 203 S. Ill., graph. Darst. : 24 cm |
| publishDate | 2002 |
| publishDateSearch | 2002 |
| publishDateSort | 2002 |
| publisher | Kluwer Academic |
| record_format | marc |
| series | Pharmaceutical biotechnology |
| series2 | Pharmaceutical biotechnology |
| spelling | Rational design of stable protein formulations theory and practice ed. by John F. Carpenter and Mark C. Manning New York Kluwer Academic 2002 XVII, 203 S. Ill., graph. Darst. : 24 cm txt rdacontent n rdamedia nc rdacarrier Pharmaceutical biotechnology 13 Includes bibliographical references and index Médicaments - Conception Médicaments protéiques - Stabilité Technologie des protéines Drug Design Drug Stability Drugs Design Protein Engineering Protein drugs Stability Protein engineering Carpenter, John F. Sonstige oth Manning, Mark C. Sonstige oth Pharmaceutical biotechnology 13 (DE-604)BV007730074 13 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009883671&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Rational design of stable protein formulations theory and practice Pharmaceutical biotechnology Médicaments - Conception Médicaments protéiques - Stabilité Technologie des protéines Drug Design Drug Stability Drugs Design Protein Engineering Protein drugs Stability Protein engineering |
| title | Rational design of stable protein formulations theory and practice |
| title_auth | Rational design of stable protein formulations theory and practice |
| title_exact_search | Rational design of stable protein formulations theory and practice |
| title_full | Rational design of stable protein formulations theory and practice ed. by John F. Carpenter and Mark C. Manning |
| title_fullStr | Rational design of stable protein formulations theory and practice ed. by John F. Carpenter and Mark C. Manning |
| title_full_unstemmed | Rational design of stable protein formulations theory and practice ed. by John F. Carpenter and Mark C. Manning |
| title_short | Rational design of stable protein formulations |
| title_sort | rational design of stable protein formulations theory and practice |
| title_sub | theory and practice |
| topic | Médicaments - Conception Médicaments protéiques - Stabilité Technologie des protéines Drug Design Drug Stability Drugs Design Protein Engineering Protein drugs Stability Protein engineering |
| topic_facet | Médicaments - Conception Médicaments protéiques - Stabilité Technologie des protéines Drug Design Drug Stability Drugs Design Protein Engineering Protein drugs Stability Protein engineering |
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