Manufacturing of Pharmaceutical Proteins : From Technology to Economy

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Cover; Contents; Preface; 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; 1.2.5 Antibiotics; 1.3 Basics of Biology; 1.3.1 Cells and Microorganisms

1.3.1.1 Structure and Types of Cells1.3.1.2 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; 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 Systems2.3.2.1 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; 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 Aids2.4.4 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; 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 Aids2.5.4.1 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; 3.2.4 Activity; 3.2.5 Appearance; 3.2.6 Stability; 3.2.7 Quality Criteria of Analytical Methods; 3.2.8 Analytical Methods; 3.2.8.1 Amino Acid Analysis; 3.2.8.2 Protein Sequencing; 3.2.8.3 Peptide Mapping; 3.2.8.4 Protein Content

3.2.8.5 Electrophoresis

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