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. Written by international experts from within the sector, this is the first book to focus on industrial pharmaceutical research. As such, it responds to the combination of such pharmaceutical interests as drug delivery, drug targeting, quality and safety management, drug approval and regulation, patenting issues and biotechnology fundamentals. The first part provides a comprehensive survey and review of the rapidly increasing array of biopharmaceuticals derived from the molecular biological approaches now widely available. This is followed by an extra section devoted to the highly critical patenting and drug regulation issues. The whole is rounded off by detailed monographs of biotechnologically developed drugs that are already on the market. In short, this text provides practitioners in pharmaceutical biotechnology with all the relevant information straight off the shelf. With a foreword of by Robert Langer, Kenneth J Germeshausen Professor of Chemical and Biomedical Engineering at the Massachusetts Institute of Technology. In 2002, he received the Charles Stark Draper Prize, the highest recognition for an engineer. Professor Langer is member of all three national academies – the Institute of Medicine, the National Academy of Engineering, and the National Academy of Sciences: "The book attempts to provide a balanced view of the biotechnological industry and the number of experts from industry sharing their knowledge and experience with the audience gives the book an outstanding value. All contributors provide with each chapter an up–to–date review on key topics in pharmaceutical biotechnology. This work is not only a valuable tool for the industrial expert but also for all pharmacists and scientists from related areas who wish to work with biotech drugs." Oliver Kayser received his PhD at the Free University Berlin in 1997 following his fellowship at the University of Gainesville, Florida, whereupon he entered the pharmaceutical biotechnology industry. He is currently a lecturer at the Department of Pharmaceutics, Biopharmacy and Biotechnology at the FU Berlin, working on new biotech drugs from natural sources and on the development of drug delivery carriers based on nanosuspension and solid lipid nanoparticle enterprise technologies. Prof. Dr. Heribert Warzecha studied Pharmazie at the Johannes Gutenberg–Universität, Mainz. After completing his Ph.D. in 1998, he worked first as a postdoctoral fellow at Cornell, USA, and become associate Professor in würzburg in 2001. Since 2007 he is full Professor at the technical university of Darmstadt and became dean of the Institute of plant science in 2009. Reviews "This textbook provides a concise overview of pharmaceutical biotechnology focusing on the industrial needs of recombinant drugs, processes, and clinical use." E–STREAMS "... international experts ... have provided precise and valuable information for the industrial experts, scientists, pharmacists, research managers..." American Journal of Therapeutics Contents Preface PART I: CONCEPTS AND METHODS FOR RECOMBINANT DRUG PRODUCTION Pharmaceutical 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 APPROVAL Overview 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: VACCINES Scientific, 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 Grand Michaela White, Evan B. Siegel, Ross Thomas Barnard) PART IV: RECENT APPLICATIONS IN PHARMACEUTICAL BIOTECHNOLOGY In 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