| Description |
1 online resource (497 p.) |
| Contents |
Cover -- Title Page -- Copyright -- Contents -- Preface to Third Edition -- Preface to First Edition -- List of Abbreviations -- Part I Introduction -- Chapter 1 Biopharmaceutical Production: Value Creation, Product Types, and Biological Basics Introduction -- 1.1 Role of Production in Pharmaceutical Biotechnology -- 1.1.1 Relationship Between Production and Development -- 1.1.2 Relationship Between Production and Marketing -- 1.2 Product Groups -- 1.2.1 Vaccines -- 1.2.2 Pharmaceuticals from Blood and Organs -- 1.2.3 Recombinant Therapeutic Proteins -- 1.2.4 Cell and Gene Therapeutics |
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1.2.5 Antibiotics -- 1.3 Basics of Biology -- 1.3.1 Cells and Microorganisms -- 1.3.1.1 Structure and Types of Cells -- 1.3.1.2 Metabolism -- 1.3.1.3 Reproduction and Aging -- 1.3.1.4 Viruses and Bacteriophages -- 1.3.1.5 Protein Biosynthesis -- 1.3.2 The Four Molecular Building Blocks of Biochemistry -- 1.3.2.1 Proteins -- 1.3.2.2 Nucleic Acids -- 1.3.2.3 Polysaccharides -- 1.3.2.4 Lipids -- Part II Technology -- Chapter 2 Manufacturing Process -- 2.1 Role of the Manufacturing Process in Biotechnology -- 2.2 Process Schematic and Evaluation -- 2.2.1 Drug Substance Manufacturing |
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2.2.2 Drug Product Manufacturing -- 2.2.3 Key Factors for Process Evaluation -- 2.3 Cell Bank -- 2.3.1 Expression Systems -- 2.3.2 Microbial Systems -- 2.3.2.1 Mammalian Systems -- 2.3.2.2 Transgenic Systems -- 2.3.3 Manufacturing and Storage of the Cell Bank -- 2.4 Fermentation -- 2.4.1 Basic Principles -- 2.4.1.1 Cell Growth and Product Expression -- 2.4.1.2 Comparison of Batch and Continuous Processes -- 2.4.1.3 Sterility and Sterile Technology -- 2.4.1.4 Comparison of Fermentation with Mammalian Cells and Microorganisms -- 2.4.2 Technologies and Equipment |
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2.4.2.1 Fermentation in Suspension Culture -- 2.4.2.2 Adherent Cell Cultures -- 2.4.2.3 Transgenic Systems -- 2.4.3 Raw Materials and Processing Aids -- 2.4.3.1 Nutrient Media -- 2.4.3.2 Water, Gases, and Other Processing Aids -- 2.4.4 Overview of Fermentation -- 2.5 Purification -- 2.5.1 Basic Principles -- 2.5.1.1 Basic Pattern of Purification -- 2.5.1.2 Types of Impurities -- 2.5.1.3 Principles of Separation Technologies -- 2.5.2 Technologies for Cell Separation and Product Isolation -- 2.5.2.1 Cell Separation -- 2.5.2.2 Cell Disruption, Solubilization, and Refolding |
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2.5.2.3 Concentration and Stabilization -- 2.5.3 Technologies for Final Purification -- 2.5.3.1 Chromatographic Processes -- 2.5.3.2 Precipitation and Extraction -- 2.5.3.3 Sterile Filtration and Virus Removal -- 2.5.4 Raw Materials and Processing Aids -- 2.5.4.1 Gels for Chromatography -- 2.5.4.2 Membranes for TFF -- 2.5.5 Overview of Purification -- 2.6 Formulation and Filling -- 2.6.1 Basic Principles -- 2.6.2 Freeze-Drying -- 2.7 Labeling and Packaging -- Chapter 3 Analytics -- 3.1 Role of Analytics in Biotechnology -- 3.2 Product Analytics -- 3.2.1 Identity -- 3.2.2 Content -- 3.2.3 Purity |
| Notes |
Description based upon print version of record |
|
3.2.4 Activity |
| Subject |
Drugs.
|
|
Pharmaceutical Preparations
|
|
Drugs
|
| Form |
Electronic book
|
| ISBN |
9783527833795 |
|
352783379X |
|
3527833803 |
|
9783527833801 |
|
3527833811 |
|
9783527833818 |
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