Oliver Kayser: 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-Universitat, Mainz. After completing his Ph.D. in 1998, he worked first as a postdoctoral fellow at Cornell, USA, and become associate Professor in wurzburg 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.

"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

• 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. Zundorf)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

Oliver Kayser: 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-Universitat, Mainz. After completing his Ph.D. in 1998, he worked first as a postdoctoral fellow at Cornell, USA, and become associate Professor in wurzburg 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.

"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

• 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. Zundorf)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

Oliver Kayser: 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-Universitat, Mainz. After completing his Ph.D. in 1998, he worked first as a postdoctoral fellow at Cornell, USA, and become associate Professor in wurzburg 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.

"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

• 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. Zundorf)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