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.
With a foreword by Robert Langer, Kenneth J Germeshausen Professor of Chemical and Biomedical Engineering at MIT and member of the National Academy of Engineering and the National Academy of Sciences.Content:
Chapter 1 Pharmaceutical Biotechnology and Industrial Applications–Learning Lessons from Molecular Biology (pages 1–13): Prof. Dr. Oliver Kayser and Prof. Dr. Heribert Warzecha
Chapter 2 Prokaryotic Cells in Biotech Production (pages 15–41): Andriy Luzhetskyy, Gabriele Weitnauer and Andreas Bechthold
Chapter 3 Mammalian Cells in Biotech Production (pages 43–57): Maria J. De Jesus and Florian M. Wurm
Chapter 4 Biopharmaceuticals from Plants (pages 59–69): Prof. Dr. Heribert Warzecha
Chapter 5 Production of Biopharmaceuticals in Transgenic Animals (pages 71–111): Heiner Niemann, Alexander Kind and Angelika Schnieke
Chapter 6 Translation of New Technologies in Biomedicines: Shaping the Road from Basic Research to Drug Development and Clinical Application–and Back Again (pages 113–152): Michael Balls, Andrew Bennett and David Kendall
Chapter 7 Overview and Classification of Approved Recombinant Drugs (pages 153–178): Theo Dingermann and Ilse Zundorf
Chapter 8 Downstream Processing (pages 179–199): Uwe Gottschalk
Chapter 9 Characterization of Recombinant Proteins (pages 201–234): Christoph Giese, Henning von Horsten and Stefan Zietze
Chapter 10 Formulation Strategies for Recombinant Protein and Related Biotech Drugs (pages 235–256): Gerhard Winter and Julia Myschik
Chapter 11 Drug Approval in the European Union and United States (pages 257–267): Gary Walsh
Chapter 12 Patents in the Pharmaceutical Biotechnology Industry: Legal and Ethical Issues (pages 269–284): David B. Resnik
Chapter 13 Biosimilar Drugs (pages 285–335): Walter Hinderer
Chapter 14 Pharmacokinetics and Pharmacodynamics of Therapeutic Peptides and Proteins (pages 337–367): Yi Zhang and Bernd Meibohm
Chapter 15 Scientific, Technical, and Economic Aspects of Vaccine Research and Development (pages 369–389): Jens?Peter Gregersen
Chapter 16 New Nanobiotechnological Strategies for the Development of Vectors for Cancer Vaccines (pages 391–421): Sean M. Geary, Caitlin D. Lemke, Yogita Krishnamachari and Aliasger K. Salem
Chapter 17 Recombinant Vaccines: Development, Production, and Application (pages 423–449): Luke R. Le Grand, Michaela White, Evan B. Siegel and Ross T. Barnard
Chapter 18 In Silico and Ultrahigh?Throughput Screenings (uHTS) in Drug Discovery: An Overview (pages 451–490): Debmalya Barh, Shoaib Ahmad and Atanu Bhattacharjee
Chapter 19 Metabolic Engineering of Medicinal Plants and Microorganisms for the Production of Natural Products (pages 491–526): Oktavia Hendrawati, Herman J. Woerdenbag, Jacques Hille and Prof. Dr. Oliver Kayser
Chapter 20 Metabolomics as a Bioanalytical Tool for Characterization of Medicinal Plants and Their Phytomedical Preparations (pages 527–552): Nizar Happyana, Remco Muntendam and Prof. Dr. Oliver Kayser
Chapter 21 Integration of Biotechnologies for the Development of Personalized Medicine (pages 553–580): Kewal K. Jain
Chapter 22 Xenotransplantation in Pharmaceutical Biotechnology (pages 581–597): Gregory J. Brunn and Jeffrey L. Platt
Chapter 23 Nutraceuticals–Functional Foods for Improving Health and Preventing Disease (pages 599–628): Jian Zhao