The biopharmaceutical market has come along way since 1982 when the first biopharmaceutical product, recombinant human insulin, was launched.
Over 120 such products are currently being marketed around the world including nine blockbuster drugs. The global market for biopharmaceuticals, which is currently valued at US$41 billion, has been growing at an impressive compound annual growth rate of 21% over the previous five years.
With over one third of all pipe-line products in active development are biopharmaceuticals, this segment is set to continue outperforming the total pharmaceutical market and could easily reach US$100 billion by the end of this decade.Content:
Chapter 1 Beginning to Understand the End of the Chromosome (pages 36โ48): Thomas R. Cech
Chapter 2 The Role of Pharmacogenetics/Pharmacogenomics in Drug Development and Regulatory Review: Current Status (pages 49โ70): Shiew?Mei Huang and Lawrence J. Lesko
Chapter 3 Large?scale Detection of Genetic Variation: The Key to Personalized Medicine (pages 71โ98): Joerg Geistlinger and Peter Ahnert
Chapter 4 A Systems Biology Approach to Target Identification and Validation for Human Chronic Disease Drug Discovery (pages 99โ125): Bonnie E. Gould Rothberg, Carol E. A. Pena and Jonathan M. Rothberg
Chapter 5 The Development of Herceptinยฎ: Paving the Way for Individualized Cancer Therapy (pages 127โ150): Thorsten S. Gutjahr and Carsten Reinhardt
Chapter 6 Adenovirus?based Gene Therapy: Therapeutic Angiogenesis with Adenovirus 5 Fibroblast Growth Factor?4 (Ad5FGF?4) in Patients with Chronic Myocardial Ischemia (pages 151โ181): Michael McCaman, Francisco J. Castillo, Farah Fawaz, Yasushi Ogawa, Erik Whiteley, Elisabeth Lehmberg, Mei Tan, Jacob Kung, Bruce Mann, Erno Pungor and Gabor M. Rubanyi
Chapter 7 MIDGE Vectors and dSLIM Immunomodulators: DNA?based Molecules for Gene Therapeutic Strategies (pages 183โ211): Manuel Schmidt, Barbara Volz and Burghardt Wittig
Chapter 8 Nonprotein?coding RNAs and their Potential as Biopharmaceuticals (pages 213โ227): Maciej Szymanski, Jan Barciszewski and Volker A. Erdmann
Chapter 9 Double?stranded Decoy Oligonucleotides as new Biopharmaceuticals (pages 229โ241): Andreas H. Wagner and Heiko E. Von der Leyen
Chapter 10 Rational siRNA Design for RNA Interference: Optimizations for Therapeutic Use and Current Applications (pages 243โ268): Anastasia Khvorova, Queta Boese and William S. Marshall
Chapter 11 The First Cloned Human Embryo: An Unlimited Source of Stem Cells for Therapeutic Cloning (pages 269โ282): Woo Suk Hwang, Byeong Chun Lee, Sung Keun Kang and Shin Yong Moon
Chapter 12 Myocardial Regeneration Strategies using Human Embryonic Stem Cells (pages 283โ304): Izhak Kehat, Oren Caspi and Lior Gepstein
Chapter 13 Gene and Cell?based Therapies for Cardiovascular Disease (pages 305โ324): Abeel A. Mangi
Chapter 14 Spheramineยฎ: A Cell Therapeutic Approach to Parkinson's Disease (pages 325โ351): Elke Reissig, Hermann Graf and Friedrich?Joachim Kapp
Chapter 15 Applying Human Cells to Organogenesis and Transplantation (pages 353โ373): Benjamin Dekel and Yair Reisner
Chapter 1 Mechanisms of Serine Proteinase Activation: Insights for the Development of Biopharmaceuticals for Coagulation and Fibrinolysis (pages 376โ393): Rainer Friedrich
Chapter 2 Application of the Principle of Polyvalency to Protease Inhibition (pages 395โ417): Luis Moroder
Chapter 3 A New Technology Standard for Safety and Efficacy in Factor VIII Replacement Therapy: Designing an Advanced Category rFVIII Concentrate (pages 419โ449): Norbert Riedel and Friedrich Dorner
Chapter 4 Biopharmaceutical Drugs from Natural Sources (pages 451โ496): David J. Newman, Gordon M. Cragg and Barry R. O'Keefe
Chapter 5 Biopharmaceuticals as Targeting Vehicles for In situ Radiotherapy of Malignancies (pages 497โ535): Raymond M. Reilly
Chapter 6 New Directions in Tumor Therapy ?Amino Acid Depletion with GlutaDONยฎ as Treatment for Cancer (pages 537โ547): Rolf Kalhammer and Natarajan Sethuraman
Chapter 7 AIDS Gene Therapy: A Vector Able to Selectively Destroy Latently HIV?1?infected Cells (pages 549โ568): Francisco Luque Vaquez and Ricardo Oya
Chapter 8 Combinatorial RNA?based Therapies for HIV?1 (pages 569โ580): Kevin V. Morris and John J. Rossi
Chapter 1 Design of Modern Biopharmaceuticals by Ultra?high?throughput Screening and Directed Evolution (pages 582โ603): Markus Rarbach, Wayne M. Coco, Andre Koltermann, Ulrich Kettling and Manfred Eigen
Chapter 2 Learning from Viruses: High?throughput Cloning using the Gateway System to Transfer Genes without Restriction Enzymes (pages 605โ620): Jonathan D. Chesnut
Chapter 3 Target Validation: An Important Early Step in the Development of Novel Biopharmaceuticals in the Post?genomic Era (pages 621โ647): Christoph P. Bagowski
Chapter 4 Genetically Modified Mice in Medical and Pharmaceutical Research (pages 649โ660): Cord Brakebusch
Chapter 5 An NIH Model Organism for Biopharmaceutical and Biomedical Research: The Lower Eukaryote Dictyostelium discoideum (pages 661โ693): Thomas Winckler, Ilse Zundorf and Theodor Dingermann
Chapter 6 Releasing the Spring: Cofactor? and Substrate?assisted Activation of Factor IXa (pages 695โ702): Hans Brandstetter and Katrin Sichler
Chapter 7 Accelerating Diagnostic Product Development Process with Molecular Rational Design and Directed Evolution (pages 703โ719): Harald Sobek, Rainer Schmuck and Zhixin Shao
Chapter 1 Manufacture of Recombinant Biopharmaceutical Proteins by Cultivated Mammalian Cells in Bioreactors (pages 723โ759): Florian M. Wurm
Chapter 2 Alternative Strategies and New Cell Lines for High?level Production of Biopharmaceuticals (pages 761โ777): Thomas Rose, Karsten Winkler, Elisabeth Brundke, Ingo Jordan and Volker Sandig
Chapter 3 PER.C6ยฎ Cells for the Manufacture of Biopharmaceutical Proteins (pages 779โ807): Chris Yallop, John Crowley, Johanne Cote, Kirsten Hegmans?Brouwer, Fija Lagerwerf, Rodney Gagne, Jose Coco Martin, Nico Oosterhuis, Dirk?Jan Opstelten and Abraham Bout
Chapter 4 Use of the Glutamine Synthetase (GS) Expression System for the Rapid Development of Highly Productive Mammalian Cell Processes (pages 809โ832): John R. Birch, David O. Mainwaring and Andrew J. Racher
Chapter 5 Biopharmaceuticals Derived from Transgenic Plants and Animals (pages 833โ892): Julio Baez
Chapter 6 Production of Recombinant Proteins in Plants (pages 893โ917): Victor Klimyuk, Sylvestre Marillonnet, Jorg Knablein, Michael McCaman and Yuri Gleba
Chapter 7 Humanized Glycosylation: Production of Biopharmaceuticals in a Moss Bioreactor (pages 919โ929): Gilbert Gorr and Sabrina Wagner
Chapter 8 ExpressTec: High?level Expression of Biopharmaceuticals in Cereal Grains (pages 931โ947): Ning Huang and Daichang Yang
Chapter 9 Biopharmaceutical Production in Cultured Plant Cells (pages 949โ965): Stefan Schillberg, Richard M. Twyman and Rainer Fischer
Chapter 10 Producing Biopharmaceuticals in the Desert: Building an Abiotic Stress Tolerance in Plants for Salt, Heat, and Drought (pages 967โ994): Shimon Gepstein, Anil Grover and Eduardo Blumwald
Chapter 11 The First Biopharmaceutical from Transgenic Animals: ATrynยฎ (pages 995โ1020): Yann Echelard, Harry M. Meade and Carol A. Ziomek
Chapter 12 Producing Modern Biopharmaceuticals: The Bayer HealthCare Pharma Experience with a Range of Expression Systems (pages 1021โ1032): Heiner Apeler
Chapter 13 Advanced Expression of Biopharmaceuticals in Yeast at Industrial Scale: The Insulin Success Story (pages 1033โ1044): Asser Sloth Andersen and Ivan Diers
Chapter 14 Baculovirus?based Production of Biopharmaceuticals using Insect Cell Culture Processes (pages 1045โ1062): Wilfried Weber and Martin Fussenegger
Chapter 15 Robust and Cost?effective Cell?free Expression of Biopharmaceuticals: Escherichia Coli and Wheat Embryo (pages 1063โ1081): Luke Anthony Miles
Chapter 16 Contract Manufacturing of Biopharmaceuticals Including Antibodies or Antibody Fragments (pages 1083โ1101): J. Carsten Hempel and Philipp N. Hess
Chapter 1 Thirty Years of Monoclonal Antibodies: A Long Way to Pharmaceutical and Commercial Success (pages 1104โ1145): Uwe Gottschalk and Kirsten Mundt
Chapter 2 Modern Antibody Technology: The Impact on Drug Development (pages 1147โ1186): Simon Moroney and Andreas Pluckthun
Chapter 3 Molecular Characterization of Autoantibody Responses in Autoimmune Diseases: Implications for Diagnosis and Understanding of Autoimmunity (pages 1187โ1209): Constanze Breithaupt
Chapter 4 Molecular Imaging and Applications for Pharmaceutical R&D (pages 1211โ1241): Joke G. Orsel and Tobias Schaeffter
Chapter 5 Design and Development of Probes for In vivo Molecular and Functional Imaging of Cancer and Cancer Therapies by Positron Emission Tomography (PET) (pages 1243โ1270): Eric O. Aboagye
Chapter 6 Ligand?based Targeting of Disease: From Antibodies to Small Organic (Synthetic) Ligands (pages 1271โ1299): Michela Silacci and Dario Neri
Chapter 7 Ultrasound Theranostics: Antibody?based Microbubble Conjugates as Targeted In vivo Contrast Agents and Advanced Drug Delivery Systems (pages 1301โ1324): Andreas Briel, Michael Reinhardt, Mathias Maurer and Peter Hauff
Chapter 8 Development of Multi?marker?based Diagnostic Assays with the ProteinChipยฎ System (pages 1325โ1342): Andreas Wiesner
Chapter 9 Early Detection of Lung Cancer: Metabolic Profiling of Human Breath with Ion Mobility Spectrometers (pages 1343โ1358): Jorg Ingo Baumbach, Wolfgang Vautz, Vera Ruzsanyi and Lutz Freitag
Chapter 1 Advanced Drug Delivery Systems for Biopharmaceuticals (pages 1360โ1391): Gesine E. Hildebrand and Stephan Harnisch
Chapter 2 Poly(ethylene) Glycol Conjugates of Biopharmaceuticals in Drug Delivery (pages 1393โ1418): Michael D. Bentley, Mary J. Bossard, Kevin W. Burton and Tacey X. Viegas
Chapter 3 Novel Vaccine Adjuvants Based on Cationic Peptide Delivery Systems (pages 1419โ1443): Karen Lingnau, Christoph Klade, Michael Buschle and Alexander Von Gabain
Chapter 4 The Evolving Role of Oralinโข (Oral Spray Insulin) in the Treatment of Diabetes using a Novel Rapid Mistโข Diabetes Management System (pages 1445โ1461): Pankaj Modi
Chapter 5 Improvement of Intestinal Absorption of Peptide and Protein Biopharmaceuticals by Various Approaches (pages 1463โ1486): Akira Yamamoto
Chapter 6 DNA Vaccine Delivery from Poly(ortho ester) Microspheres (pages 1487โ1506): Chun Wang, Herman N. Eisen, Robert Langer and Jorge Heller
Chapter 7 Liposomal In vivo Gene Delivery (pages 1507โ1519): Shigeru Kawakami, Fumiyoshi Yamashita and Mitsuru Hashida
Chapter 8 Programmed Packaging: A New Drug Delivery System and its Application to Gene Therapy (pages 1521โ1536): Kentaro Kogure, Hidetaka Akita, Hiroyuki Kamiya and Hideyoshi Harashima
Chapter 9 Bionanotechnology and its Role to Improve Biopharmaceuticals (pages 1537โ1554): Oliver Kayser
Chapter 1 Analytics in Quality Control and In vivo (pages 1556โ1579): Michael Hildebrand
Chapter 2 Design, Development and Optimization: Crystal Structures of Microsomal Cytochromes P450 (pages 1581โ1602): Dijana Matak Vinkovic, Sheena Whyte, Harren Jhoti, Jose Cosme and Pamela A. Williams
Chapter 3 Mettoxโข: A Suite of Predictive In silico and In vitro Assays for Metabolic and Genotoxicological Profiling of Preclinical Drug Candidates (pages 1603โ1636): Michael Murray
Chapter 4 Considerations for Developing Biopharmaceuticals: FDA Perspective (pages 1637โ1667): Kurt Brorson, Patrick G. Swann, Janice Brown, Barbara Wilcox and Marjorie A. Shapiro
Chapter 5 The Regulatory Environment for Biopharmaceuticals in the EU (pages 1669โ1708): Axel F. Wenzel and Carina E. A. Sonnega
Chapter 1 Healthcare Trends and their Impact on the Biopharmaceutical Industry: Biopharmaceuticals Come of Age (pages 1710โ1740): Alexander Moscho, Markus A. Schafer and Kristin Yarema
Chapter 2 mondoBIOTECH: The Swiss biotech BOUTIQUE (pages 1741โ1754): Dorian Bevec and Fabio Cavalli
Chapter 3 G?CSF and Bioequivalence: The Emergence of Healthcare Economics (pages 1755โ1769): James Harris
Chapter 4 Bioinformatics: From Peptides to Profiled Leads (pages 1771โ1801): Paul Wrede and Matthias Filter
Chapter 5 Engineering and Overproduction of Polyketide Natural Products (pages 1803โ1832): Martha Lovato Tse and Chaitan Khosla