Pharmaceutical Biotechnology

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.

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.

PrefacePART I: CONCEPTS AND METHODS FOR RECOMBINANT DRUG PRODUCTIONPharmaceutical Biotechnology and Industrial Applications: Learning Lessons from Molecular Biology (Oliver Kayser, Heribert Warzecha)Procaryotic Cells in Biotech Production (Andriy Luzhetskyy, Gabriele Weitnauer, Andreas Bechtold)Mammalian Cells in Biotech Production (Maria J. De Jesus and Florian M. Wurm)Biopharmaceuticals from Plants (Heribert Warzecha)The Production of Biopharmaceuticals in Transgenic Animals (Heiner Niemann, Alexander Kind, Angelika Schnieke)Translation of New Technologies in Biomedicines: Shaping the Road from Basic Research to Drug Development and Clinical Application - and Back Again (Michael Balls, Andrew Bennett, David Kendall)PART II: BRINGING THE DRUG INTO ACTION - FROM DOWNSTREAMING TO APPROVALOverview and Classification of Approved Recombinant Drugs (Theo Dingermann, I. Zündorf)Downstream Processing (Uwe Gottschalk)Characterization of Recombinant Proteins (Christoph Giese, Henning von Horsten, Stefan Zietze)Formulation Strategies for Recombinant Protein and Related Biotech Drugs (Gerhard Winter, Julia Myschik)Drug Approval in the European Union and United States (Gary Walsh)Patents in the Pharmaceutical Biotechnology Industry: Legal and Ethical Issues (David B. Resnick)Biosimilar Drugs (Walter Hinderer)Pharmacokinetics and Pharmacodynamics of Therapeutic Peptides and Proteins (Yi Zhang, Bernd Meibohm)PART III: VACCINESScientific, Technical and Economic Aspects of Vaccine Research and Development (Jens Peter Gregersen)New Nanobiotechnological Strategies for the Development of Vectors for Cancer Vaccines (Sean M. Geary, Caitlin D. Lemke, Yogita Krishnamachari, Aliasger K. Salem)Recombinant Vaccines: Development, Production and Application (Luke Richard Le GrandMichaela White, Evan B. Siegel, Ross Thomas Barnard)PART IV: RECENT APPLICATIONS IN PHARMACEUTICAL BIOTECHNOLOGYIn Silico and Ultra-high Throughput Screenings (uHTS) in Drug Discovery: An Overview (Debmalya Barh, Shoaib Ahmad, Atanu Bhattacharjee)Metabolic Engineering of Medicinal Plants and Microorganisms for the Production of Natural Products (O Kayser, J Hille, HJ Woerdenbag)Metabolomics as Bioanalytical Tool for Characterization of Medicinal Plants and their Phytomedical Preparations (Nizar Happyana, Remco Muntendam, Oliver Kayser)Integration of Biotechnologies for the Development of Personalized Medicine (Kewal Jain)Xenotransplantation in Pharmaceutical Biotechnology (Gregory J. Brunn and Jeffrey L. Platt)Nutraceuticals/Functional Foods for Improving Health and Preventing Disease (Jian Zhao)Index