Efnisyfirlit

• Cover
• Related Titles
• Title page
• Copyright page
• Preface to the 2nd Edition
• List of Contributors
• Part One: Concepts and Methods for Recombinant Drug Production
• 1 Pharmaceutical Biotechnology and Industrial Applications – Learning Lessons from Molecular Biology
• 1.1 Introduction
• 1.2 Research Developments
• 1.3 Production Hosts and Upstream/Downstream Processing
• 1.4 Future Outlook
• 2 Prokaryotic Cells in Biotech Production
• 2.1 Introduction
• 2.2 Production of Natural Products by Microorganisms
• 2.3 Prokaryotes as Producers of Recombinant Therapeutic Proteins
• 3 Mammalian Cells in Biotech Production
• 3.1 Introduction
• 3.2 Process Concepts and Cells
• 3.3 CHO-Derived Production Cell Lines
• 3.4 Rapid Generation of High-Producing Cell Lines
• 3.5 Silencing – Stability of Expression
• 3.6 High-Throughput Bioprocess Development
• 3.7 Disposable Bioreactors
• 3.8 Transient Gene Expression (TGE)
• 3.9 Conclusions
• 4 Biopharmaceuticals from Plants
• 4.1 Introduction
• 4.2 Basics in Plant Biotechnology
• 4.3 Plant Cell Cultures as Production System for Human Glucocerebrosidase
• 4.4 Insulin from Safflower – A Unique Purification Scheme
• 4.5 Fast and Scalable Transient Tobacco-Based Expression Systems
• 4.6 Conclusion
• 5 Production of Biopharmaceuticals in Transgenic Animals
• 5.1 Introduction
• 5.2 Sites of Production
• 5.3 Transgenic Constructs
• 5.4 Methods for the Production of Transgenic Animals
• 5.5 Analysis of Transgenic Animals
• 5.6 Quality and Safety of the Product
• 5.7 Conclusions and Outlook
• 6 Translation of New Technologies in Biomedicines: Shaping the Road from Basic Research to Drug Development and Clinical Application – and Back Again
• 6.1 Drug Discovery and Development
• 6.2 The Nature of Models and the Need for Them
• 6.3 New Technologies Toolbox
• 6.4 Strategic Use of the New Technology Tools
• 6.5 Translation as a Two-Way Process
• 6.6 Concluding Comment
• Part Two: Bringing the Drug into Action – From Downstreaming to Approval
• 7 Overview and Classification of Approved Recombinant Drugs
• 7.1 Introduction
• 7.2 Classification of Recombinant Drugs from a Technical Point of View
• 7.3 Expression Systems
• 7.4 Proteins Derived from Modified Genes
• 7.5 Artificial Proteins
• 7.6 Post-expression Modifications of Recombinant Proteins
• 7.7 Biosimilars
• 8 Downstream Processing
• 8.1 Introduction
• 8.2 General Principles of DSP
• 8.3 Clarification
• 8.4 Chromatography
• 8.5 Ultrafiltration/Diafiltration, and Virus Filtration
• 8.6 Crystallization
• 8.7 Recent Developments in Downstream Processing
• 9 Characterization of Recombinant Proteins
• 9.1 Introduction
• 9.2 Physical Chemical Characterization
• 9.3 Biological Characterization of Biopharmaceuticals In Vitro
• Acknowledgments
• Legals
• 10 Formulation Strategies for Recombinant Protein and Related Biotech Drugs
• 10.1 Introduction
• 10.2 Formulation and Stability of Protein Solutions
• 10.3 Formulation of Vaccines
• 11 Drug Approval in the European Union and United States
• 11.1 Introduction
• 11.2 Regulation within the European Union
• 11.3 Regulation in the United States of America
• 11.4 International Regulatory Harmonization
• 11.5 Regulation of Biosimilars
• 12 Patents in the Pharmaceutical Biotechnology Industry: Legal and Ethical Issues
• 12.1 Introduction
• 12.2 Patent Law
• 12.3 Ethical and Policy Issues in Biotechnology Patents
• 12.4 Conclusion
• 13 Biosimilar Drugs
• 13.1 Introduction
• 13.2 Recombinant Therapeutic Proteins
• 13.3 Definition of Biosimilars
• 13.4 Regulatory Situation
• 13.5 Patent Situation
• 13.6 First Wave of Biosimilars in the EU
• 13.7 Biosimilar Targets: Second Wave of Future Biosimilars
• 13.8 Biosimilar Developments and Requirements
• 13.9 Conclusions
• 14 Pharmacokinetics and Pharmacodynamics of Therapeutic Peptides and Proteins
• 14.1 Introduction
• 14.2 Pharmacokinetics of Peptides and Proteins
• 14.3 Immunogenicity and Protein Pharmacokinetics
• 14.4 Exposure–Response Correlations for Protein Therapeutics
• 14.5 Summary and Conclusions
• Part Three: Vaccines
• 15 Scientific, Technical, and Economic Aspects of Vaccine Research and Development
• 15.1 Introduction
• 15.2 From the Research Concept to a Development Candidate
• 15.3 Vaccine Research Projects
• 15.4 Scientific Challenges of Vaccine R&D
• 15.5 Technical Aspects of Vaccine Development
• 15.6 Economic Aspects of Vaccine Development
• 15.7 Conclusions
• 16 New Nanobiotechnological Strategies for the Development of Vectors for Cancer Vaccines
• 16.1 Introduction
• 16.2 Biodegradable Nanoparticles
• 16.3 Liposomal Nanovectors
• 16.4 Gelatin Nanoparticles
• 16.5 Sub-micron Emulsions
• 16.6 Amphiphilic Block-Graft Copolymers
• 16.7 Iron Oxide Nanoparticles
• 16.8 Viruses–Virus-Like Particles–Virosomes
• 16.9 Conclusion
• Acknowledgments
• 17 Recombinant Vaccines: Development, Production, and Application
• 17.1 Introduction
• 17.2 Range of Recombinant Vaccines on the Market and in Development Today
• 17.3 Vaccine Dialectic
• 17.4 Comparing Vaccine Efficacy
• 17.5 Vaccines: A Brief Overview
• 17.6 Recombinant Vaccine Development
• 17.7 Delivery Systems
• 17.8 At the Vanguard
• 17.9 Novel, Recombinant DNA Approach to Identifying Attenuated Vaccine Strains
• 17.10 Clinical Trials
• 17.11 Conclusion
• Part Four: Recent Applications in Pharmaceutical Biotechnology
• 18 In Silico and Ultrahigh-Throughput Screenings (uHTS) in Drug Discovery: an Overview
• 18.1 Introduction
• 18.2 In Silico Pharmacology and Virtual Ligand Screening for Drug Discovery
• 18.3 Lead Discovery Using Integrative Virtual Screening
• 18.4 Application of Microarray Technology in HTS and Drug Discovery
• 18.5 Chemical Proteomics for Drug Discovery and Development
• 18.6 Target and Drug Discovery Using Lipomic Profiling
• 18.7 Drug Discovery Using Integrative Genomics
• 18.8 Toxicogenomics in Drug Discovery and Development
• 18.9 HTP RNAi Screening for Targeted Drug Discovery
• 18.10 High-Throughput Screening with Stem Cells
• 18.11 Systems Biology in Drug Discovery
• 18.12 Conclusion
• 19 Metabolic Engineering of Medicinal Plants and Microorganisms for the Production of Natural Products
• 19.1 Introduction
• 19.2 The Plant as a Source of Natural Products
• 19.3 Optimizing Biochemical Pathways
• 19.4 Metabolic Engineering Strategies and Techniques in Medicinal Plant Biotechnology
• 19.5 Challenges in Plant Metabolic Engineering
• 19.6 Metabolic Engineering Applications in Medicinal Plant Biotechnology
• 19.7 Crossing Borders – Heterologous Production of Plant Compounds in Microorganisms
• 19.8 Conclusion and Future Prospects
• 20 Metabolomics as a Bioanalytical Tool for Characterization of Medicinal Plants and Their Phytomedical Preparations
• 20.1 Introduction
• 20.2 Bioanalytical Tools
• 20.3 Metabolomics Applications in Medicinal Plants
• 20.4 Conclusions
• Acknowledgment
• 21 Integration of Biotechnologies for the Development of Personalized Medicine
• 21.1 Introduction
• 21.2 Genetic Variations in the Human Genome
• 21.3 Role of Biomarkers in the Development of Personalized Medicine
• 21.4 Technologies Used for the Development of Personalized Medicine
• 21.5 Molecular Diagnosis as a Basis for Personalized Medicine
• 21.6 Sequencing and Personalized Medicine
• 21.7 Role of Biochips/Microarrays in the Development of Personalized Medicine
• 21.8 Role of Cytogenetics in the Development of Personalized Medicine
• 21.9 Role of “Omics” in Personalized Medicine
• 21.10 Role of Nanobiotechnology for the Development of Personalized Medicine
• 21.11 Systems Biology and Personalized Medicine
• 21.12 Personalized Biological Therapies
• 21.13 Personalized Vaccines
• 21.14 Concluding Remarks and Future Prospects of Personalized Medicine
• 22 Xenotransplantation in Pharmaceutical Biotechnology
• 22.1 Introduction
• 22.2 Biological Barriers to Xenotransplantation
• 22.3 Physiological and Infectious Hurdles to Xenotransplantation
• 22.4 Scenario for the Clinical Application of Xenotransplantation
• 23 Nutraceuticals–Functional Foods for Improving Health and Preventing Disease
• 23.1 Introduction
• 23.2 Plant Food, Pharmaceuticals, Nutraceuticals, and Human Health
• 23.3 Concepts of Functional Foods, Nutraceuticals, and Other Related Terms
• 23.4 FFN Principles and Their Potential Health Benefits
• 23.5 Herbal Nutraceuticals and Multiple Herbal Component Formulations
• 23.6 FFNs and Metabolic Syndrome, Facial Aging, and Cosmetic Surgery
• 23.7 Absorption and Metabolism of FFNs and Interaction with Drugs
• 23.8 Epidermiological Study and Clinical Trials on FFNs
• 23.9 Biotechnology for Improved Nutritional Value and Creation of Medical Foods
• 23.10 Future Developments
• Index