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Contents
Introduction
Chapter 1 Introduction of Biopharmaceuticals 1
1 Basic Concept of Biotech Drugs 1
2 History of Biopharmaceutical Industries 4
3 Categorization and Characteristics of Biotech Drug 7
3.1 Classified by Sources 7
3.2 Classified by Function and Purpose 9
3.3 Characteristics of Biotechnology Medicine 9
4 Research Progress on Biotech Drugs 11
References 16
Chapter 2 Biopharmaceuticals Manufacturing17
1 Manufacturing Platforms 19
1.1 Mammalian Cell Expression Platform 22
1.2 Microbial Expression Platforms 28
1.3 Other Expression Platforms 34
2 Manufacturing Process 39
2.1 Upstream Manufacturing Process 43
2.2 Downstream Manufacturing Process 45
2.3 Manufacturing Process by E.coli Expression System 49
2.4 Therapeutic Antibody Production Process 52
2.5 Manufacturing Facility and Process Validation 54
2.6 Single-Use Technology in Biopharmaceutical Manufacturing 57
References 61
Chapter 3 Formulations of Biopharmaceuticals 62
1 Structural Characteristics and Physicochemical Properties of Biopharmaceuticals 62
2 Formulation Recipes and Processing of Biopharmaceuticals 64
2.1 Preformulation Study 64
2.2 Recipes Design 67
2.3 Processing of Protein and Polypeptide as Injection Drugs 71
3 New Biotech Drug Delivery System 74
3.1 New Injection Drug Delivery System 75
3.2 Non-injection Drug Delivery System 82
3.3 Preparation Examples of Biotech Drug Delivery System 89
References 91
Chapter 4 Quality Aspect of Biopharmaceutical Manufacturing 93
1 Good Manufacturing Practice (GMP) 94
1.1 GMP Key Points in Biopharmaceutical Manufacturing 96
1.2 Quality Control of P.R.China99
1.3 Quality Control of United States and Europe 101
1.4 Quality Control of World Health Organization (WHO) 105
2 GMP Guidelines 106
2.1 WHO Guidelines 106
2.2 FDA Guidelines 107
2.3 ICH Guidelines 107
3 Pharmacopoeia 109
3.1 International Pharmacopeia 109
3.2 United State Pharmacopeia 110
3.3 European Pharmacopoeia 111
4 Vaccine Safety and Regulatory Controls 112
References 115
Chapter 5 Gene Engineering Drugs116
1 Interleukin 116
1.1 Introduction of Interleukin 116
1.2 Interleukin-11 119
2 Interferon 137
2.1 Introduction of Interferon 137
2.2 ClassificationofInterferon 138
2.3 The Biological Effects of Interferon 144
2.4 The Interferon Preparation Process 147
2.5 Quality Control and Safety Standards of Interferon 154
3 Tumor Necrosis Factor (TNF) 161
3.1 Introduction of TNF 161
3.2 Molecular Structures and Gene of TNF 161
3.3 TNF-R 162
3.4 Biological Activities of TNF 163
3.5 TNF: Therapeutic Aspects 168
3.6 Status and Prospects of TNF 169
4 Insulin 172
4.1 Introduction of Insulin 173
4.2 Production of Human Insulin by Recombinant DNA Technology 182
4.3 Therapeutic Uses of Insulin and Means of Administration 192
5 Erythrop