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3.5 Manipulation of Cell Growth, Metabolism and Product Quality Attributes
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Hans Henning von Horsten
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Chapters in this book
- Frontmatter I
- Preface V
- Contents VII
- List of Contributing Authors IX
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1. Introduction
- 1.1 Industrial Use and Perspectives of Animal Cell Culture 1
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2. Cell Lines
- 2.1 Generation of Cell Lines and Biotechnological Applications 11
- 2.2 CHO History, CHO Evolution and CHO Genomics – an Unsolvable Enigma? 38
- 2.3 Cell Lines for Vaccine Production 60
- 2.4 Cell Line Monitoring: Molecular Cytogenetic Characterization 87
- 2.5 Quality Control Essentials in Human Cell Culture: Cell Line Cross-contamination and Microbiological Infections 102
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3. Genetic Engineering of Cells
- 3.1 Cell Line Evolution and Engineering 115
- 3.2 Chromosome Rearrangements and Gene Amplification 127
- 3.3 Synthetic Biology Principles for Engineering Mammalian Designer Cells 144
- 3.4 Rational Approaches for Transgene Expression: Targeted Integration and Episomal Maintenance 173
- 3.5 Manipulation of Cell Growth, Metabolism and Product Quality Attributes 216
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4. Engineering of the Product
- 4.1 Control of Biotheraputics Glycosylation 247
- 4.2 Manufacturing of Complex Biotherapeutic Protein Products: Medical Need and Rational for Monoclonal Antibody Mixtures, Multispecific Formats, and Fc-fusion Proteins 280
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5. Basic Aspects of Animal Cell Cultivation
- 5.1 Physiology and Metabolism of Animal Cells for Production 301
- 5.2 Functional -Omics for Cell Lines and Processes: The -Omics Technologies on the Example of CHO Cells 326
- 5.3 Nutrient Media for Cell Culture Technology 368
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6. Upstream and Downstream Process Technology
- 6.1 Bioreactors for Animal Cell Culture 389
- 6.2 High Cell Density Cultivation Process 427
- 6.3 Industrial Cell Culture Process Scale-up Strategies and Considerations 455
- 6.4 Extraction and Purification of Biologics from Cell Culture: Monoclonal Antibody Downstream Processing 489
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7. Monitoring and Control of Processes and Products
- 7.1 Concepts and Technologies for Advanced Process Monitoring and Control 523
- 7.2 Analytical Techniques and Quality Control of Protein Therapeutics 571
- 7.3 Process Characterization for Upstream and Downstream Process Development 598
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8. Pharmaceutical Aspects of Biologics from Animal Cell Culture Processes
- 8.1 Spatiotemporally Controlled Delivery of Biopharmaceuticals 649
- Index 693
Chapters in this book
- Frontmatter I
- Preface V
- Contents VII
- List of Contributing Authors IX
-
1. Introduction
- 1.1 Industrial Use and Perspectives of Animal Cell Culture 1
-
2. Cell Lines
- 2.1 Generation of Cell Lines and Biotechnological Applications 11
- 2.2 CHO History, CHO Evolution and CHO Genomics – an Unsolvable Enigma? 38
- 2.3 Cell Lines for Vaccine Production 60
- 2.4 Cell Line Monitoring: Molecular Cytogenetic Characterization 87
- 2.5 Quality Control Essentials in Human Cell Culture: Cell Line Cross-contamination and Microbiological Infections 102
-
3. Genetic Engineering of Cells
- 3.1 Cell Line Evolution and Engineering 115
- 3.2 Chromosome Rearrangements and Gene Amplification 127
- 3.3 Synthetic Biology Principles for Engineering Mammalian Designer Cells 144
- 3.4 Rational Approaches for Transgene Expression: Targeted Integration and Episomal Maintenance 173
- 3.5 Manipulation of Cell Growth, Metabolism and Product Quality Attributes 216
-
4. Engineering of the Product
- 4.1 Control of Biotheraputics Glycosylation 247
- 4.2 Manufacturing of Complex Biotherapeutic Protein Products: Medical Need and Rational for Monoclonal Antibody Mixtures, Multispecific Formats, and Fc-fusion Proteins 280
-
5. Basic Aspects of Animal Cell Cultivation
- 5.1 Physiology and Metabolism of Animal Cells for Production 301
- 5.2 Functional -Omics for Cell Lines and Processes: The -Omics Technologies on the Example of CHO Cells 326
- 5.3 Nutrient Media for Cell Culture Technology 368
-
6. Upstream and Downstream Process Technology
- 6.1 Bioreactors for Animal Cell Culture 389
- 6.2 High Cell Density Cultivation Process 427
- 6.3 Industrial Cell Culture Process Scale-up Strategies and Considerations 455
- 6.4 Extraction and Purification of Biologics from Cell Culture: Monoclonal Antibody Downstream Processing 489
-
7. Monitoring and Control of Processes and Products
- 7.1 Concepts and Technologies for Advanced Process Monitoring and Control 523
- 7.2 Analytical Techniques and Quality Control of Protein Therapeutics 571
- 7.3 Process Characterization for Upstream and Downstream Process Development 598
-
8. Pharmaceutical Aspects of Biologics from Animal Cell Culture Processes
- 8.1 Spatiotemporally Controlled Delivery of Biopharmaceuticals 649
- Index 693