Manufacturing of pharmaceutical proteins: from technology to economy
Saved in:
| Main Author: | |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
Weinheim
WILEY-VCH
2009
|
| Subjects: | |
| Online Access: | Inhaltstext Inhaltsverzeichnis |
| Physical Description: | XIV, 390 S. Ill., graph. Darst. |
| ISBN: | 9783527324446 |
Staff View
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Titel: Manufacturing of pharmaceutical proteins
Autor: Behme, Stefan
Jahr: 2009
i
Contents
' Preface XIII
Part One Introduction 1
1 Biopharmaceutical Production: Value Creation, Product
Types and Biological Basics 3
1.1 Role of Production in Pharmaceutical Biotechnology 3
1.1.1 Relationship between Production and Development 6
1.1.2 Relationship between Production and Marketing 8
1.2 Product Groups 10
1.2.1 Vaccines 11
1.2.2 Pharmaceuticals from Blood and Organs 13
1.2.3 Recombinant Therapeutic Proteins 13
1.2.4 Cell and Gene Therapeutics 13
1.2.5 Antibiotics 36
1.3 Basics of Biology 17
1.3.1 Cells and Microorganisms 17
1.3.1.1 Structure and Types of Cells 18
' 1.3.1.2 Metabolism 21
1.3.1.3 Reproduction and Aging 22
1.3.1.4 Viruses and Bacteriophages 23
1.3.1.5 Protein Biosynthesis 24
1.3.2 The Four Molecular Building Blocks of Biochemistry 26
1.3.2.1 Proteins 26
1.3.2.2 Nucleic Acids 31
1.3.2.3 Polysaccharides 31
1.3.2.4 Lipids 32
Part Two Technology 33
2 Manufacturing Process 35
2.1 Role of the Manufacturing Process
in Biotechnology 35
2.2 Process Schematic and Evaluation 37
¦ Manufacturing of Pharmaceutical Proteins: From Technology to Economy. Stefan Behme
Copyright © 2009 WILEY-VCH Verlag GmbH Co. KGaA, Weinheim
ISBN: 978-3-527-32444-6
VI Contents
2.2.1 Drug Substance Manufacturing 38
2.2.2 Drug Product Manufacturing 40
2.2.3 Key Factors for Process Evaluation 41
2.3 Cell Bank 43
2.3.1 Expression Systems 43
2.3.1.1 Microbial Systems 43
2.3.1.2 Metazoan Systems 45
2.3.1.3 Transgenic Systems 46
2.3.2 Manufacturing and Storage of the Cell Bank 46
2.4 Fermentation 48
2.4.1 Basic Principles 48
2A.I.I Cell Growth and Product Expression 48
2.4.1.2 Comparison of Batch and Continuous Processes 50
2.4.1.3 Sterility and Sterile Technology 52
2.4.1.4 Comparison of Fermentation with Mammalian
Cells and Microorganisms 54
2.4.2 Technologies and Equipment 55
2.4.2.1 Fermentation in Suspension Culture 55
2.4.2.2 Adherent Cell Cultures 56
2.4.2.3 Transgenic Systems 59
2.4.3 Raw Materials and Processing Aids 60
2.4.3.1 Nutrient Media 60
2.4.3.2 Water, Gases and Other Processing Aids 61
2.4.4 Overview of Fermentation 62
2.5 Purification 63
2.5.1 Basic Principles 64
2.5.1.1 Basic Pattern of Purification 64
2.5.1.2 Types of Impurities 68
2.5.1.3 Principles of Separation Technologies 70
2.5.2 Technologies for Cell Separation and Product Isolation 72
2.5.2.1 Cell Separation 72
2.5.2.2 Cell Disruption, Solubilization and Refolding 73
2.5.2.3 Concentration and Stabilization 75
2.5.3 Technologies for Final Purification 79
2.5.3.1 Chromatographic Processes 80
2.5.3.2 Precipitation and Extraction 88
2.5.3.3 Sterile Filtration and Virus Removal 89
2.5.4 Raw Materials and Processing Aids 90
2.5.4.1 Gels for Chromatography 90
2.5.4.2 Membranes for TFF 92
2.5.5 Overview of purification 93
2.6 Formulation and Filling 95
2.6.1 Basic Principles 95
2.6.2 Freeze-Drying 97
2.7 Labeling and Packaging 98
Contents VII
3 Analytics 101
3.1 Role of Analytics in Biotechnology 101
3.2 Product Analytics 103
3.2.1 Identity 104
3.2.2 Content 106
' 3.2.3 Purity 106
3.2.4 Activity 107
3.2.5 Appearance 109
3.2.6 Stability 110
3.2.7 Quality Criteria of Analytical Methods 111
3.2.8 Analytical Methods 112
3.2.8.1 Amino Acid Analysis 113
3.2.8.2 Protein Sequencing 113
3.2.8.3 Peptide Mapping 114
3.2.8.4 Protein Content 114
3.2.8.5 Electrophoresis 115
3.2.8.6 Western Blot 117
3.2.8.7 HCP enzyme-linked immunosorbent assay
(ELISA) 119
3.2.8.8 Analytical Chromatography 120
3.2.8.9 Infrared (IR) Spectroscopy 122
3.2.8.10 UV/Vis Spectroscopy 122
3.2.8.11 Mass Spectrometry 123
3.2.8.12 Glycoanalytics 124
3.2.8.13 PCR 124
3.2.8.14 DNA/RNA Sequencing 125
3.2.8.15 Endotoxins and Pyrogen Testing 126
3.2.8.16 Bioburden Test 126
3.2.8.17 Virus Testing 127
3.2.8.18 TEM 127
3.2.8.19 Circular Dichroism 127
3.2.8.20 Differential Scanning Calorimetry 128
3.3 Process Analytics 128
3.3.1 Fermentation 129
3.3.2 Purification 129
3.3.3 Formulation and Packaging 131
3.4 Environmental Monitoring 132
3.5 Raw Material Testing 133
3.6 Product Comparability 134
Part Three Pharmacy 137
4 Pharmacology and Drug Safety 139
4.1 Action of Drugs in Humans 140
4.1.1 Pharmacokinetics 141
4.1.2 Pharmacodynamics 144
VIII Contents
4.1.2.1 Principles of Phenomenological Effects 145
4.1.2.2 Parameters of Drug Effects 146
4.2 Routes and Forms of Administration 148
43 Drug Study 149
4.3.1 Pre-Clinical Study 151
4.3.2 Clinical Study 152
4.3.2.1 Phases of Clinical Studies 153
4.3.2.2 Design and Conduct of Clinical Trials 155
4.4 Path of the Drug from the Manufacturer
to Patients 158
4.5 Drug Safety 159
4.5.1 Causes and Classification of Side-Effects 160
4.5.2 Methods of Supervising Drug Safety
(Pharmacovigilance) 162
4.5.3 Measures at Incidence of Adverse Reactions 362
Part Four Quality Assurance 365
5 Fundamentals of Quality Assurance 167
5.1 Basic Principles 167
5.2 Benefit of Quality Assurance Activities 267
5.3 Quality Management According to ISO 9000 169
5.3.1 Fields of Activity 169
5.4 Structure of Quality Management Systems 171
5.5 Quality Management System Components
in the Pharmaceutical Area 173
5.5.1 Documentation 273
5.5.2 Failure Prevention and Correction 274
5.5.3 Responsibility of Management and Training
of Personnel 2 78
5.5.4 Audits 279
5.5.5 External Suppliers 180
5.5.6 Contract Review 181
5.6 Quality Assurance in Development 282
6 Quality Assurance in Manufacturing 183
6.1 GMP 183
6.1.1 Personnel 188
6.1.2 Premises and Equipment 289
6.1.2.1 Measures to Avoid External Contamination 189
6.1.2.2 Measures to Avoid Cross-Contamination and
Product Confusion 192
6.1.3 Equipment Qualification 195
6.1.4 Process Validation 297
6.1.5 Computer Validation 299
6.1.6 Documentation 200
Contents IX
6.2 Operative Workflows under GMP Conditions 201
6.2.1 Product Release and Deviation Management 201
6.2.2 Changes in the Manufacturing Process 203
6.3 Production of Investigational Drugs 207
Part Five Pharmaceutical Law 209
7 Pharmaceutical Law and Regulatory Authorities 211
7.1 Fields of Pharmaceutical Law 211
7.2 Bindingness of Regulations 212
7.3 Authorities, Institutions and their Regulations 213
7.3.1 FDA 214
7.3.2 EMEA 216
7.3.3 German Authorities 218
7.3.4 Japanese Authorities 220
7.3.5 Other Important Institutions 221
7.4 Official Enforcement of Regulations 224
7.5 Drug Approval 225
Part Six Production Facilities 227
8 Facility Design 229
8.1 Basic Principles 229
8.2 GMP-Compliant Plant Design 233
8.2.1 Production Flow Diagram 234
8.2.2 Conceptual Plant Layout 236
8.2.3 GMP Flow Analysis 239
8.2.4 Zoning Concept 243
8.3 Basic Concepts for Production Plants 246
8.3.1 Single-and Multi-Product Plants 248
8.3.2 Fractal and Integrated Configuration 250
8.3.3 Flexible and Fixed Piping 251
8.3.4 Steel Tanks and Disposable Equipment 253
8.4 Clean and Plant Utilities 254
8.4.1 Clean Utilities 254
8.4.1.1 Water 254
8.4.1.2 Clean Steam 260
8.4.1.3 Gases and Process Air 261
8.4.2 Plant Utilities 261
8.4.3 Waste Management 263
8.5 Equipment Cleaning 265
8.6 Clean-Rooms 266
8.6.1 Separation of Zones by Clean-Room Design 267
8.6.2 Finishing of Floors, Walls and Ceilings 269
8.6.3 HVAC Installations 269
8.6.4 Qualification 270
8.7 Automation 271
X Contents
8.8 Quality Control Laboratories 273
8.9 Location Factors 273
9 Planning, Construction and Commissioning
of a Manufacturing Plant 277
9.1 Steps of the Engineering Project 277
9.1.1 Planning 278
9.1.2 Construction 279
9.1.3 Commissioning, Qualification, Validation 279
9.2 Project Schedules 283
9.3 Cost Estimates 285
9.4 Organization of an Engineering Project 286
9.4.1 Expert Groups Involved 286
9.4.2 Role and Selection of Contractors 287
9.4.3 Contracts and Scope Changes 288
9.5 Successful Execution of an Engineering Project 292
9.6 Legal Aspects of Facility Engineering 292
9.6.1 Health, Safety and Environmental Law 293
9.6.2 Building Law 294
Part Seven Economy 297
10 Product Sales and Manufacturing Costs 299
10.1 Lifecycle of a Drug 299
10.2 Position of the Manufacturing Costs in the Overall
Cost Framework 303
10.2.1 Basic Principles of Cost Calculation 305
10.2.1.1 Nominal Accounting - Actual Accounting 305
10.2.1.2 Cost Accounting - Profit and Loss Accounting 306
10.2.1.3 Direct Costs - Overhead Costs 306
10.2.1.4 Fixed Costs - Variable Costs 306
10.2.1.5 Relevant and Irrelevant Costs 308
10.2.1.6 Cost Type, Cost Center and Cost Unit 308
10.3 Manufacturing Costs 309
10.3.1 Cost Types 310
10.3.1.1 Depreciation 311
10.3.1.2 Interest 311
10.3.2 Typical Costs of Biotechnological Manufacturing
Processes 312
10.3.3 Methods of Calculation 313
10.3.3.1 Cost Calculations 319
10.3.3.2 Profit and Loss Calculation 323
11 Investments 325
11.1 Basic Principles 326
11.1.1 Investment Targets 326
Contents XI
11.1.2 Types of Investments 326
11.1.2.1 Classification According to the Object
of Investment 327
11.1.2.2 Classification According to the Effect
of Investment 328
11.1.2.3 Classification According to Other Criteria 328
11.1.3 Decision Processes 329
11.2 Value-Benefit Analysis 332
11.3 Investment Appraisal 334
11.3.1 Static Methods 337
11.3.1.1 Cost Comparison 338
11.3.1.2 Profit Comparison 338
11.3.1.3 Profitability Comparison 338
11.3.1.4 Static Payback Time 339
11.3.2 Dynamic Methods 339
11.3.2.1 Capital Value 339
11.3.2.2 Internal Rate of Return 340
11.3.2.3 Annuity 340
11.3.2.4 Dynamic Payback Time 341
12 Production Concept 343
12.1 Capacity Planning 343
12.2 Dilemma of In-House Manufacturing 346
12.3 Aspects of Manufacturing Out-Sourcing 349
12.3.1 Types of Cooperation 350
12.3.2 Contractual Agreements 351
12.3.3 Technology Transfer 352
12.3.4 Time Schedules 354
12.4 Make-or-Buy Analysis 355
12.5 Process Optimization after Market Launch 357
12.6 Supply-Chain Management 359
References 363
Index of Abbreviations 369
Index 375 |
| any_adam_object | 1 |
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| callnumber-label | RS431 |
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| callnumber-subject | RS - Pharmacy |
| classification_rvk | VS 5000 |
| ctrlnum | (OCoLC)277069400 (DE-599)DNB990246507 |
| dewey-full | 615.19 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615.19 |
| dewey-search | 615.19 |
| dewey-sort | 3615.19 |
| dewey-tens | 610 - Medicine and health |
| discipline | Chemie / Pharmazie Medizin |
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| indexdate | 2024-07-20T10:01:11Z |
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| language | English |
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| spellingShingle | Behme, Stefan Manufacturing of pharmaceutical proteins from technology to economy Proteinpräparat - Pharmazeutische Technologie Drug Industry economics Pharmaceutical industry Protein drugs Proteins chemical synthesis Proteins therapeutic use Technology, Pharmaceutical organization & administration Pharmazeutische Technologie (DE-588)4045699-7 gnd Proteinpräparat (DE-588)4247384-6 gnd |
| subject_GND | (DE-588)4045699-7 (DE-588)4247384-6 |
| title | Manufacturing of pharmaceutical proteins from technology to economy |
| title_auth | Manufacturing of pharmaceutical proteins from technology to economy |
| title_exact_search | Manufacturing of pharmaceutical proteins from technology to economy |
| title_full | Manufacturing of pharmaceutical proteins from technology to economy Stefan Behme |
| title_fullStr | Manufacturing of pharmaceutical proteins from technology to economy Stefan Behme |
| title_full_unstemmed | Manufacturing of pharmaceutical proteins from technology to economy Stefan Behme |
| title_short | Manufacturing of pharmaceutical proteins |
| title_sort | manufacturing of pharmaceutical proteins from technology to economy |
| title_sub | from technology to economy |
| topic | Proteinpräparat - Pharmazeutische Technologie Drug Industry economics Pharmaceutical industry Protein drugs Proteins chemical synthesis Proteins therapeutic use Technology, Pharmaceutical organization & administration Pharmazeutische Technologie (DE-588)4045699-7 gnd Proteinpräparat (DE-588)4247384-6 gnd |
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