Modern biopharmaceuticals. V.4, Design, development and optimization /
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ISBN：9783527311842
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简介
Due to the impressive accumulation of out-standing results, presented by brilliant, privileged and creative thinkers, this unique book reads like the ‘Who is Who’ of biotechnology. Never before has such an impressive group of individuals contributed to one biotechnology book, including Nobel Prize laureates Robert Huber, Thomas R. Cech, and Manfred Eigen as well as authors from the world's most famous academic institutes and biotech companies, such as ETH Zurich, MIT, Stanford, Yale, Princeton, Harvard Medical School, Max-Planck-Institute, Fraunhofer-Institute, Moscow Academy of Sciences, London Imperial College and Baxter, Invitrogen, MorphoSys, Roche, and Schering AG. Published as a comprehensive four volume set, this title also includes a CD-ROMcontaining additional information and videos. Modern Biopharmaceuticals describes: THE FIRST cloned human embryo THE FIRST myocardial regeneration with embryonic stem cells THE FIRST artificial kidney THE FIRST biopharmaceutical from a transgenic animal THE FIRST individualized medicine THE FIRST plasma-free Factor VIII THE FIRST approved human cell line THE FIRST oral insulin, etc. “... an outstanding collection of articles from groundbreaking scientists, comprehensively describing the many novel ways cells are being deployed toward human good ...” James D. Watson, “DNA Codebreaker” & Nobel Prize Laureate (Physiology or Medicine, 1962) Modern Biopharmaceuticals is an essential reference work for biotechnologists, clinicians, medical doctors, pharmacists, pharmaceutical chemists, bio-chemists, molecular biologists, medicinal chemists, as well as all those working in the biotechnological and pharmaceutical industries, or medicinal institutes.
目录
Table of contents Frontmatter (pages I–CXXXVIII)
Beginning to Understand the End of the Chromosome (pages 36–48)Thomas R. Cech
The Role of Pharmacogenetics/Pharmacogenomics in Drug Development and Regulatory Review: Current Status (pages 49–70)Shiew-Mei Huang and Lawrence J. Lesko
Large-scale Detection of Genetic Variation: The Key to Personalized Medicine (pages 71–98)Joerg Geistlinger and Peter Ahnert
A Systems Biology Approach to Target Identification and Validation for Human Chronic Disease Drug Discovery (pages 99–125)Bonnie E. Gould Rothberg, Carol E. A. Peña and Jonathan M. Rothberg
The Development of Herceptin®: Paving the Way for Individualized Cancer Therapy (pages 127–150)Thorsten S. Gutjahr and Carsten Reinhardt
Adenovirus-based Gene Therapy: Therapeutic Angiogenesis with Adenovirus 5 Fibroblast Growth Factor-4 (Ad5FGF-4) in Patients with Chronic Myocardial Ischemia (pages 151–181)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
MIDGE Vectors and dSLIM Immunomodulators: DNA-based Molecules for Gene Therapeutic Strategies (pages 183–211)Manuel Schmidt, Barbara Volz and Burghardt Wittig
Nonprotein-coding RNAs and their Potential as Biopharmaceuticals (pages 213–227)Maciej Szymanski, Jan Barciszewski and Volker A. Erdmann
Double-stranded Decoy Oligonucleotides as new Biopharmaceuticals (pages 229–241)Andreas H. Wagner and Heiko E. Von der Leyen
Rational siRNA Design for RNA Interference: Optimizations for Therapeutic Use and Current Applications (pages 243–268)Anastasia Khvorova, Queta Boese and William S. Marshall
The First Cloned Human Embryo: An Unlimited Source of Stem Cells for Therapeutic Cloning (pages 269–282)Woo Suk Hwang, Byeong Chun Lee, Sung Keun Kang and Shin Yong Moon
Myocardial Regeneration Strategies using Human Embryonic Stem Cells (pages 283–304)Izhak Kehat, Oren Caspi and Lior Gepstein
Gene and Cell-based Therapies for Cardiovascular Disease (pages 305–324)Abeel A. Mangi
Spheramine®: A Cell Therapeutic Approach to Parkinson's Disease (pages 325–351)Elke Reissig, Hermann Graf and Friedrich-Joachim Kapp
Applying Human Cells to Organogenesis and Transplantation (pages 353–373)Benjamin Dekel and Yair Reisner
Mechanisms of Serine Proteinase Activation: Insights for the Development of Biopharmaceuticals for Coagulation and Fibrinolysis (pages 376–393)Rainer Friedrich
Application of the Principle of Polyvalency to Protease Inhibition (pages 395–417)Luis Moroder
A New Technology Standard for Safety and Efficacy in Factor VIII Replacement Therapy: Designing an Advanced Category rFVIII Concentrate (pages 419–449)Norbert Riedel and Friedrich Dorner
Biopharmaceutical Drugs from Natural Sources (pages 451–496)David J. Newman, Gordon M. Cragg and Barry R. O'Keefe
Biopharmaceuticals as Targeting Vehicles for In situRadiotherapy of Malignancies (pages 497–535)Raymond M. Reilly
New Directions in Tumor Therapy -Amino Acid Depletion with GlutaDON® as Treatment for Cancer (pages 537–547)Rolf Kalhammer and Natarajan Sethuraman
AIDS Gene Therapy: A Vector Able to Selectively Destroy Latently HIV-1-infected Cells (pages 549–568)Francisco Luque Váquez and Ricardo Oya
Combinatorial RNA-based Therapies for HIV-1 (pages 569–580)Kevin V. Morris and John J. Rossi
Design of Modern Biopharmaceuticals by Ultra-high-throughput Screening and Directed Evolution (pages 582–603)Markus Rarbach, Wayne M. Coco, Andre Koltermann, Ulrich Kettling and Manfred Eigen
Learning from Viruses: High-throughput Cloning using the Gateway System to Transfer Genes without Restriction Enzymes (pages 605–620)Jonathan D. Chesnut
Target Validation: An Important Early Step in the Development of Novel Biopharmaceuticals in the Post-genomic Era (pages 621–647)Christoph P. Bagowski
Genetically Modified Mice in Medical and Pharmaceutical Research (pages 649–660)Cord Brakebusch
An NIH Model Organism for Biopharmaceutical and Biomedical Research: The Lower Eukaryote Dictyostelium discoideum(pages 661–693)Thomas Winckler, Ilse Zündorf and Theodor Dingermann
Releasing the Spring: Cofactor- and Substrate-assisted Activation of Factor IXa (pages 695–702)Hans Brandstetter and Katrin Sichler
Accelerating Diagnostic Product Development Process with Molecular Rational Design and Directed Evolution (pages 703–719)Harald Sobek, Rainer Schmuck and Zhixin Shao
Manufacture of Recombinant Biopharmaceutical Proteins by Cultivated Mammalian Cells in Bioreactors (pages 723–759)Florian M. Wurm
Alternative Strategies and New Cell Lines for High-level Production of Biopharmaceuticals (pages 761–777)Thomas Rose, Karsten Winkler, Elisabeth Brundke, Ingo Jordan and Volker Sandig
PER.C6® Cells for the Manufacture of Biopharmaceutical Proteins (pages 779–807)Chris Yallop, John Crowley, Johanne Cote, Kirsten Hegmans-Brouwer, Fija Lagerwerf, Rodney Gagne, Jose Coco Martin, Nico Oosterhuis, Dirk-Jan Opstelten and Abraham Bout
Use of the Glutamine Synthetase (GS) Expression System for the Rapid Development of Highly Productive Mammalian Cell Processes (pages 809–832)John R. Birch, David O. Mainwaring and Andrew J. Racher
Biopharmaceuticals Derived from Transgenic Plants and Animals (pages 833–892)Julio Baez
Production of Recombinant Proteins in Plants (pages 893–917)Victor Klimyuk, Sylvestre Marillonnet, Jörg Knäblein, Michael McCaman and Yuri Gleba
Humanized Glycosylation: Production of Biopharmaceuticals in a Moss Bioreactor (pages 919–929)Gilbert Gorr and Sabrina Wagner
ExpressTec: High-level Expression of Biopharmaceuticals in Cereal Grains (pages 931–947)Ning Huang and Daichang Yang
Biopharmaceutical Production in Cultured Plant Cells (pages 949–965)Stefan Schillberg, Richard M. Twyman and Rainer Fischer
Producing Biopharmaceuticals in the Desert: Building an Abiotic Stress Tolerance in Plants for Salt, Heat, and Drought (pages 967–994)Shimon Gepstein, Anil Grover and Eduardo Blumwald
The First Biopharmaceutical from Transgenic Animals: ATryn® (pages 995–1020)Yann Echelard, Harry M. Meade and Carol A. Ziomek
Producing Modern Biopharmaceuticals: The Bayer HealthCare Pharma Experience with a Range of Expression Systems (pages 1021–1032)Heiner Apeler
Advanced Expression of Biopharmaceuticals in Yeast at Industrial Scale: The Insulin Success Story (pages 1033–1044)Asser Sloth Andersen and Ivan Diers
Baculovirus-based Production of Biopharmaceuticals using Insect Cell Culture Processes (pages 1045–1062)Wilfried Weber and Martin Fussenegger
Robust and Cost-effective Cell-free Expression of Biopharmaceuticals: Escherichia Coliand Wheat Embryo (pages 1063–1081)Luke Anthony Miles
Contract Manufacturing of Biopharmaceuticals Including Antibodies or Antibody Fragments (pages 1083–1101)J. Carsten Hempel and Philipp N. Hess
Thirty Years of Monoclonal Antibodies: A Long Way to Pharmaceutical and Commercial Success (pages 1104–1145)Uwe Gottschalk and Kirsten Mundt
Modern Antibody Technology: The Impact on Drug Development (pages 1147–1186)Simon Moroney and Andreas Plückthun
Molecular Characterization of Autoantibody Responses in Autoimmune Diseases: Implications for Diagnosis and Understanding of Autoimmunity (pages 1187–1209)Constanze Breithaupt
Molecular Imaging and Applications for Pharmaceutical R&D (pages 1211–1241)Joke G. Orsel and Tobias Schaeffter
Design and Development of Probes for In vivoMolecular and Functional Imaging of Cancer and Cancer Therapies by Positron Emission Tomography (PET) (pages 1243–1270)Eric O. Aboagye
Ligand-based Targeting of Disease: From Antibodies to Small Organic (Synthetic) Ligands (pages 1271–1299)Michela Silacci and Dario Neri
Ultrasound Theranostics: Antibody-based Microbubble Conjugates as Targeted In vivoContrast Agents and Advanced Drug Delivery Systems (pages 1301–1324)Andreas Briel, Michael Reinhardt, Mathias Mäurer and Peter Hauff
Development of Multi-marker-based Diagnostic Assays with the ProteinChip® System (pages 1325–1342)Andreas Wiesner
Early Detection of Lung Cancer: Metabolic Profiling of Human Breath with Ion Mobility Spectrometers (pages 1343–1358)Jörg Ingo Baumbach, Wolfgang Vautz, Vera Ruzsanyi and Lutz Freitag
Advanced Drug Delivery Systems for Biopharmaceuticals (pages 1360–1391)Gesine E. Hildebrand and Stephan Harnisch
Poly(ethylene) Glycol Conjugates of Biopharmaceuticals in Drug Delivery (pages 1393–1418)Michael D. Bentley, Mary J. Bossard, Kevin W. Burton and Tacey X. Viegas
Novel Vaccine Adjuvants Based on Cationic Peptide Delivery Systems (pages 1419–1443)Karen Lingnau, Christoph Klade, Michael Buschle and Alexander Von Gabain
The Evolving Role of Oralin™ (Oral Spray Insulin) in the Treatment of Diabetes using a Novel Rapid Mist™ Diabetes Management System (pages 1445–1461)Pankaj Modi
Improvement of Intestinal Absorption of Peptide and Protein Biopharmaceuticals by Various Approaches (pages 1463–1486)Akira Yamamoto
DNA Vaccine Delivery from Poly(ortho ester) Microspheres (pages 1487–1506)Chun Wang, Herman N. Eisen, Robert Langer and Jorge Heller
Liposomal In vivoGene Delivery (pages 1507–1519)Shigeru Kawakami, Fumiyoshi Yamashita and Mitsuru Hashida
Programmed Packaging: A New Drug Delivery System and its Application to Gene Therapy (pages 1521–1536)Kentaro Kogure, Hidetaka Akita, Hiroyuki Kamiya and Hideyoshi Harashima
Bionanotechnology and its Role to Improve Biopharmaceuticals (pages 1537–1554)Oliver Kayser
Analytics in Quality Control and In vivo(pages 1556–1579)Michael Hildebrand
Design, Development and Optimization: Crystal Structures of Microsomal Cytochromes P450 (pages 1581–1602)Dijana Matak Vinkovič, Sheena Whyte, Harren Jhoti, Jose Cosme and Pamela A. Williams
Mettox™: A Suite of Predictive In silicoand In vitroAssays for Metabolic and Genotoxicological Profiling of Preclinical Drug Candidates (pages 1603–1636)Michael Murray
Considerations for Developing Biopharmaceuticals: FDA Perspective (pages 1637–1667)Kurt Brorson, Patrick G. Swann, Janice Brown, Barbara Wilcox and Marjorie A. Shapiro
The Regulatory Environment for Biopharmaceuticals in the EU (pages 1669–1708)Axel F. Wenzel and Carina E. A. Sonnega
Healthcare Trends and their Impact on the Biopharmaceutical Industry: Biopharmaceuticals Come of Age (pages 1710–1740)Alexander Moscho, Markus A. Schäfer and Kristin Yarema
mondoBIOTECH: The Swiss biotech BOUTIQUE (pages 1741–1754)Dorian Bevec and Fabio Cavalli
G-CSF and Bioequivalence: The Emergence of Healthcare Economics (pages 1755–1769)James Harris
Bioinformatics: From Peptides to Profiled Leads (pages 1771–1801)Paul Wrede and Matthias Filter
Engineering and Overproduction of Polyketide Natural Products (pages 1803–1832)Martha Lovato Tse and Chaitan Khosla
Beginning to Understand the End of the Chromosome (pages 36–48)Thomas R. Cech
The Role of Pharmacogenetics/Pharmacogenomics in Drug Development and Regulatory Review: Current Status (pages 49–70)Shiew-Mei Huang and Lawrence J. Lesko
Large-scale Detection of Genetic Variation: The Key to Personalized Medicine (pages 71–98)Joerg Geistlinger and Peter Ahnert
A Systems Biology Approach to Target Identification and Validation for Human Chronic Disease Drug Discovery (pages 99–125)Bonnie E. Gould Rothberg, Carol E. A. Peña and Jonathan M. Rothberg
The Development of Herceptin®: Paving the Way for Individualized Cancer Therapy (pages 127–150)Thorsten S. Gutjahr and Carsten Reinhardt
Adenovirus-based Gene Therapy: Therapeutic Angiogenesis with Adenovirus 5 Fibroblast Growth Factor-4 (Ad5FGF-4) in Patients with Chronic Myocardial Ischemia (pages 151–181)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
MIDGE Vectors and dSLIM Immunomodulators: DNA-based Molecules for Gene Therapeutic Strategies (pages 183–211)Manuel Schmidt, Barbara Volz and Burghardt Wittig
Nonprotein-coding RNAs and their Potential as Biopharmaceuticals (pages 213–227)Maciej Szymanski, Jan Barciszewski and Volker A. Erdmann
Double-stranded Decoy Oligonucleotides as new Biopharmaceuticals (pages 229–241)Andreas H. Wagner and Heiko E. Von der Leyen
Rational siRNA Design for RNA Interference: Optimizations for Therapeutic Use and Current Applications (pages 243–268)Anastasia Khvorova, Queta Boese and William S. Marshall
The First Cloned Human Embryo: An Unlimited Source of Stem Cells for Therapeutic Cloning (pages 269–282)Woo Suk Hwang, Byeong Chun Lee, Sung Keun Kang and Shin Yong Moon
Myocardial Regeneration Strategies using Human Embryonic Stem Cells (pages 283–304)Izhak Kehat, Oren Caspi and Lior Gepstein
Gene and Cell-based Therapies for Cardiovascular Disease (pages 305–324)Abeel A. Mangi
Spheramine®: A Cell Therapeutic Approach to Parkinson's Disease (pages 325–351)Elke Reissig, Hermann Graf and Friedrich-Joachim Kapp
Applying Human Cells to Organogenesis and Transplantation (pages 353–373)Benjamin Dekel and Yair Reisner
Mechanisms of Serine Proteinase Activation: Insights for the Development of Biopharmaceuticals for Coagulation and Fibrinolysis (pages 376–393)Rainer Friedrich
Application of the Principle of Polyvalency to Protease Inhibition (pages 395–417)Luis Moroder
A New Technology Standard for Safety and Efficacy in Factor VIII Replacement Therapy: Designing an Advanced Category rFVIII Concentrate (pages 419–449)Norbert Riedel and Friedrich Dorner
Biopharmaceutical Drugs from Natural Sources (pages 451–496)David J. Newman, Gordon M. Cragg and Barry R. O'Keefe
Biopharmaceuticals as Targeting Vehicles for In situRadiotherapy of Malignancies (pages 497–535)Raymond M. Reilly
New Directions in Tumor Therapy -Amino Acid Depletion with GlutaDON® as Treatment for Cancer (pages 537–547)Rolf Kalhammer and Natarajan Sethuraman
AIDS Gene Therapy: A Vector Able to Selectively Destroy Latently HIV-1-infected Cells (pages 549–568)Francisco Luque Váquez and Ricardo Oya
Combinatorial RNA-based Therapies for HIV-1 (pages 569–580)Kevin V. Morris and John J. Rossi
Design of Modern Biopharmaceuticals by Ultra-high-throughput Screening and Directed Evolution (pages 582–603)Markus Rarbach, Wayne M. Coco, Andre Koltermann, Ulrich Kettling and Manfred Eigen
Learning from Viruses: High-throughput Cloning using the Gateway System to Transfer Genes without Restriction Enzymes (pages 605–620)Jonathan D. Chesnut
Target Validation: An Important Early Step in the Development of Novel Biopharmaceuticals in the Post-genomic Era (pages 621–647)Christoph P. Bagowski
Genetically Modified Mice in Medical and Pharmaceutical Research (pages 649–660)Cord Brakebusch
An NIH Model Organism for Biopharmaceutical and Biomedical Research: The Lower Eukaryote Dictyostelium discoideum(pages 661–693)Thomas Winckler, Ilse Zündorf and Theodor Dingermann
Releasing the Spring: Cofactor- and Substrate-assisted Activation of Factor IXa (pages 695–702)Hans Brandstetter and Katrin Sichler
Accelerating Diagnostic Product Development Process with Molecular Rational Design and Directed Evolution (pages 703–719)Harald Sobek, Rainer Schmuck and Zhixin Shao
Manufacture of Recombinant Biopharmaceutical Proteins by Cultivated Mammalian Cells in Bioreactors (pages 723–759)Florian M. Wurm
Alternative Strategies and New Cell Lines for High-level Production of Biopharmaceuticals (pages 761–777)Thomas Rose, Karsten Winkler, Elisabeth Brundke, Ingo Jordan and Volker Sandig
PER.C6® Cells for the Manufacture of Biopharmaceutical Proteins (pages 779–807)Chris Yallop, John Crowley, Johanne Cote, Kirsten Hegmans-Brouwer, Fija Lagerwerf, Rodney Gagne, Jose Coco Martin, Nico Oosterhuis, Dirk-Jan Opstelten and Abraham Bout
Use of the Glutamine Synthetase (GS) Expression System for the Rapid Development of Highly Productive Mammalian Cell Processes (pages 809–832)John R. Birch, David O. Mainwaring and Andrew J. Racher
Biopharmaceuticals Derived from Transgenic Plants and Animals (pages 833–892)Julio Baez
Production of Recombinant Proteins in Plants (pages 893–917)Victor Klimyuk, Sylvestre Marillonnet, Jörg Knäblein, Michael McCaman and Yuri Gleba
Humanized Glycosylation: Production of Biopharmaceuticals in a Moss Bioreactor (pages 919–929)Gilbert Gorr and Sabrina Wagner
ExpressTec: High-level Expression of Biopharmaceuticals in Cereal Grains (pages 931–947)Ning Huang and Daichang Yang
Biopharmaceutical Production in Cultured Plant Cells (pages 949–965)Stefan Schillberg, Richard M. Twyman and Rainer Fischer
Producing Biopharmaceuticals in the Desert: Building an Abiotic Stress Tolerance in Plants for Salt, Heat, and Drought (pages 967–994)Shimon Gepstein, Anil Grover and Eduardo Blumwald
The First Biopharmaceutical from Transgenic Animals: ATryn® (pages 995–1020)Yann Echelard, Harry M. Meade and Carol A. Ziomek
Producing Modern Biopharmaceuticals: The Bayer HealthCare Pharma Experience with a Range of Expression Systems (pages 1021–1032)Heiner Apeler
Advanced Expression of Biopharmaceuticals in Yeast at Industrial Scale: The Insulin Success Story (pages 1033–1044)Asser Sloth Andersen and Ivan Diers
Baculovirus-based Production of Biopharmaceuticals using Insect Cell Culture Processes (pages 1045–1062)Wilfried Weber and Martin Fussenegger
Robust and Cost-effective Cell-free Expression of Biopharmaceuticals: Escherichia Coliand Wheat Embryo (pages 1063–1081)Luke Anthony Miles
Contract Manufacturing of Biopharmaceuticals Including Antibodies or Antibody Fragments (pages 1083–1101)J. Carsten Hempel and Philipp N. Hess
Thirty Years of Monoclonal Antibodies: A Long Way to Pharmaceutical and Commercial Success (pages 1104–1145)Uwe Gottschalk and Kirsten Mundt
Modern Antibody Technology: The Impact on Drug Development (pages 1147–1186)Simon Moroney and Andreas Plückthun
Molecular Characterization of Autoantibody Responses in Autoimmune Diseases: Implications for Diagnosis and Understanding of Autoimmunity (pages 1187–1209)Constanze Breithaupt
Molecular Imaging and Applications for Pharmaceutical R&D (pages 1211–1241)Joke G. Orsel and Tobias Schaeffter
Design and Development of Probes for In vivoMolecular and Functional Imaging of Cancer and Cancer Therapies by Positron Emission Tomography (PET) (pages 1243–1270)Eric O. Aboagye
Ligand-based Targeting of Disease: From Antibodies to Small Organic (Synthetic) Ligands (pages 1271–1299)Michela Silacci and Dario Neri
Ultrasound Theranostics: Antibody-based Microbubble Conjugates as Targeted In vivoContrast Agents and Advanced Drug Delivery Systems (pages 1301–1324)Andreas Briel, Michael Reinhardt, Mathias Mäurer and Peter Hauff
Development of Multi-marker-based Diagnostic Assays with the ProteinChip® System (pages 1325–1342)Andreas Wiesner
Early Detection of Lung Cancer: Metabolic Profiling of Human Breath with Ion Mobility Spectrometers (pages 1343–1358)Jörg Ingo Baumbach, Wolfgang Vautz, Vera Ruzsanyi and Lutz Freitag
Advanced Drug Delivery Systems for Biopharmaceuticals (pages 1360–1391)Gesine E. Hildebrand and Stephan Harnisch
Poly(ethylene) Glycol Conjugates of Biopharmaceuticals in Drug Delivery (pages 1393–1418)Michael D. Bentley, Mary J. Bossard, Kevin W. Burton and Tacey X. Viegas
Novel Vaccine Adjuvants Based on Cationic Peptide Delivery Systems (pages 1419–1443)Karen Lingnau, Christoph Klade, Michael Buschle and Alexander Von Gabain
The Evolving Role of Oralin™ (Oral Spray Insulin) in the Treatment of Diabetes using a Novel Rapid Mist™ Diabetes Management System (pages 1445–1461)Pankaj Modi
Improvement of Intestinal Absorption of Peptide and Protein Biopharmaceuticals by Various Approaches (pages 1463–1486)Akira Yamamoto
DNA Vaccine Delivery from Poly(ortho ester) Microspheres (pages 1487–1506)Chun Wang, Herman N. Eisen, Robert Langer and Jorge Heller
Liposomal In vivoGene Delivery (pages 1507–1519)Shigeru Kawakami, Fumiyoshi Yamashita and Mitsuru Hashida
Programmed Packaging: A New Drug Delivery System and its Application to Gene Therapy (pages 1521–1536)Kentaro Kogure, Hidetaka Akita, Hiroyuki Kamiya and Hideyoshi Harashima
Bionanotechnology and its Role to Improve Biopharmaceuticals (pages 1537–1554)Oliver Kayser
Analytics in Quality Control and In vivo(pages 1556–1579)Michael Hildebrand
Design, Development and Optimization: Crystal Structures of Microsomal Cytochromes P450 (pages 1581–1602)Dijana Matak Vinkovič, Sheena Whyte, Harren Jhoti, Jose Cosme and Pamela A. Williams
Mettox™: A Suite of Predictive In silicoand In vitroAssays for Metabolic and Genotoxicological Profiling of Preclinical Drug Candidates (pages 1603–1636)Michael Murray
Considerations for Developing Biopharmaceuticals: FDA Perspective (pages 1637–1667)Kurt Brorson, Patrick G. Swann, Janice Brown, Barbara Wilcox and Marjorie A. Shapiro
The Regulatory Environment for Biopharmaceuticals in the EU (pages 1669–1708)Axel F. Wenzel and Carina E. A. Sonnega
Healthcare Trends and their Impact on the Biopharmaceutical Industry: Biopharmaceuticals Come of Age (pages 1710–1740)Alexander Moscho, Markus A. Schäfer and Kristin Yarema
mondoBIOTECH: The Swiss biotech BOUTIQUE (pages 1741–1754)Dorian Bevec and Fabio Cavalli
G-CSF and Bioequivalence: The Emergence of Healthcare Economics (pages 1755–1769)James Harris
Bioinformatics: From Peptides to Profiled Leads (pages 1771–1801)Paul Wrede and Matthias Filter
Engineering and Overproduction of Polyketide Natural Products (pages 1803–1832)Martha Lovato Tse and Chaitan Khosla
Modern biopharmaceuticals. V.4, Design, development and optimization /
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