Includes bibliographical references and index

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 Production3.1 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 Systems4.6 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 Toolbox6.4 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 DSP8.3 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

Available to OhioLINK libraries

"This second edition of a very successful book is thoroughly updated with existing chapters completely rewritten while the content has more than doubled from 16 to 36 chapters. As with the first edition, the focus is on industrial pharmaceutical research, written by a team of industry experts from around the world, while quality and safety management, drug approval and regulation, patenting issues, and biotechnology fundamentals are also covered. In addition, this new edition now not only includes biotech drug development but also the use of biopharmaceuticals in diagnostics and vaccinations."--Provided by publisher