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Produktbild: Biotechnology and Biopharmaceuticals

Biotechnology and Biopharmaceuticals Transforming Proteins and Genes into Drugs

Fr. 222.00

inkl. gesetzl. MwSt., Versandkostenfrei

Beschreibung

Produktdetails

Einband

Taschenbuch

Erscheinungsdatum

16.12.2013

Verlag

John Wiley & Sons

Seitenzahl

744

Maße (L/B/H)

27.9/21.5/3.8 cm

Gewicht

1602 g

Auflage

2nd edition

Sprache

Englisch

ISBN

978-1-118-17979-6

Beschreibung

Rezension

"Overall, this book provides a valuable resource that can be utilized as a quick look-up guide and, more importantly, as an educational tool that can be used in strategic planning. The presentation style provides comprehensive information amenable to a diverse audience." ( Clinical Infectious Diseases , 30 October 2014)

Produktdetails

Einband

Taschenbuch

Erscheinungsdatum

16.12.2013

Verlag

John Wiley & Sons

Seitenzahl

744

Maße (L/B/H)

27.9/21.5/3.8 cm

Gewicht

1602 g

Auflage

2nd edition

Sprache

Englisch

ISBN

978-1-118-17979-6

Herstelleradresse

Libri GmbH
Europaallee 1
36244 Bad Hersfeld
DE

Email: GPSR Kontakt

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  • Produktbild: Biotechnology and Biopharmaceuticals
  • Contributors xiii

    Foreword xv

    Preface xvii

    Preface to the First Edition xix

    Acknowledgments xxi

    Organization of the Book xxiii

    User Agreement xxv

    Part I
    Transforming Proteins and Genes into Drugs--The Science and the Art 1

    1 Introduction to Biopharmaceuticals 3

    Abstract 3

    1.1 Background and Significance 4

    1.2 Translation of Biotechnology for Developing Biopharmaceuticals 7

    1.3 Historical Perspective of Pharmaceutical Biotechnology 8

    1.4 Distinctions between Chemical Drugs Versus Biopharmaceuticals 8

    1.5 Summary 10

    2 Distinctions of Biologic Versus Small Molecule Platforms in Drug Development 13

    Abstract 13

    2.1 Introduction 14

    2.2 Transforming New Molecules into Drugs: The Drug Development Process 14

    2.3 Key Differences between Biotechnology and Chemical Products 16

    2.4 Current Trends in Drug Development 18

    2.5 Summary 22

    3 Financing Biologic Drug Development 23

    Abstract 23

    3.1 Introduction 24

    3.2 The Role of the Orphan Drug Act 27

    3.3 Clinical Leverage Strategy in Accelerating Drug Development 30

    3.4 Therapeutic Target Considerations 32

    3.5 Evolving Trends 34

    3.6 Summary 36

    4 Application of Biotechnology in Drug Discovery and Early Development 39

    Abstract 39

    4.1 Introduction 40

    4.2 Data Mining, Molecular Cloning, and Characterization 40

    4.3 Optimization of Cell Expression Systems and Product Yield 50

    4.4 Molecular Optimization 51

    4.5 Proteins and Genes as Targets for Drug Discovery and Development 56

    4.6 Summary 58

    5 Large-Scale Production of Recombinant Proteins 63

    Abstract 63

    5.1 Introduction 64

    5.2 Yield Optimization in Genetic Constructs and Host Cells 65

    5.3 Large-Scale Cultivation of Host Cells 66

    5.4 Downstream Processing and Purification 70

    5.5 Quality Assurance and Quality Control 75

    5.6 Summary 77

    6 Clinical Pharmacology, Toxicology, and Therapeutic Dosage and Response 79

    Abstract 79

    6.1 Introduction 80

    6.2 Clinical Pharmacology and Toxicology 80

    6.3 Dose and Therapeutic Response 95

    6.4 Dosage Form and Route of Administration 97

    6.5 Summary 99

    7 Clinical Evaluation and Regulatory Approval and Enforcement of Biopharmaceuticals 103

    Abstract 103

    7.1 Introduction: Biologic Drug Development and Approval 104

    7.2 Licensing of Biological Products 104

    7.3 Preclinical and Clinical Testing 107

    7.4 FDA Review and Approval Process 114

    7.5 Regulatory Enforcement 118

    7.6 Globalization of Drug Approval (Chien*) 118

    7.7 Summary 122

    8 Pharmacoeconomics and Drug Pricing (Garrison*) 125

    Abstract 125

    8.1 Introduction: Pharmacoeconomics 126

    8.2 Cost-Effectiveness: Assessing the Value of Biopharmaceuticals 126

    8.3 The Cost of Developing Biopharmaceuticals 128

    8.4 Pricing Biopharmaceuticals 131

    8.5 Drug Development Incentives 133

    8.6 Economics of Biosimilars 133

    8.7 Economic Impact of Personalized Medicine 134

    8.8 Summary and Future Challenges 135

    Part II
    Therapeutic and Clinical Applications of Biopharmaceu ticals--Proteins and Nucleic Acids 137

    9 Antibodies and Derivatives 139

    Abstract 139

    Section One 140

    9.1 Molecular Characteristics and Therapeutic Applications 140

    9.1.1 Introduction 140

    9.1.2 Historical Perspective--Discovery, Classification, Biodistribution, and Physiological Characteristics of Antibody Molecules 140

    9.1.3 Gamma Globulin and Hyperimmune Globulin 144

    9.1.4 Monoclonal Antibodies--From Mouse, Mouse-Human Chimeric, Humanized, to Human Monoclonal Antibodies 145

    9.1.5 Antibody Derivatives 147

    9.1.6 Disposition of Antibodies 149

    9.1.7 Extravascular Tissue Penetration 155

    9.1.8 Mechanisms of Antibody Bioactivities 156

    9.1.9 Antibody Conjugates 156

    9.1.10 Antibodies and Derivatives in Development 158

    9.1.11 Summary 159

    Section Two 162

    9.2 Antibodies and Derivatives Monographs List 162

    9.3 Antibodies and Derivatives Monographs 163

    10 Hematopoietic Growth and Coagulation Factors 211

    Abstract 211

    Section One 212

    10.1 Molecular Characteristics and Therapeutic Applications 212

    10.1.1 Introduction 212

    10.1.2 Hematopoietic Growth and Coagulation Factors 212

    10.1.3 Therapeutic Use of Hematopoietic Growth Factors (Molineux, Elliott*) 218

    10.1.4 Therapeutic Use of Coagulation and Anticoagulation Factors 225

    10.1.5 Summary 229

    Section Two 231

    10.2 Hematopoietic Growth and Coagulation Factors List 231

    10.3 Hematopoietic Growth and Coagulation Factors Monographs 231

    11 Cytokines and Interferons 251

    Abstract 251

    Section One 252

    11.1 Molecular Characteristics and Therapeutic Applications 252

    11.1.1 Introduction 252

    11.1.2 Interleukins as Immunotherapeutics 252

    11.1.3 Interferon Biology and Cancer Therapy (Tiu, Koon, Borden*) 256

    11.1.4 Interferons as Antiviral Therapy 271

    11.1.5 Interferons in Multiple Sclerosis 275

    11.1.6 Summary 280

    Section Two 288

    11.2 Cytokines and Interferons Monographs List 288

    11.3 Cytokines and Interferons Monographs 288

    12 Hormones 307

    Abstract 307

    Section One 308

    12.1 Molecular Characteristics and Therapeutic Applications 308

    12.1.1 Introduction 308

    12.1.2 Peptide Hormones and Clinical Significance 308

    12.1.3 Therapeutic Application of Recombinant and

    Synthetic Hormones 309

    12.1.4 Summary 318

    Section Two 320

    12.2 Hormones Monographs List 320

    12.3 Hormones Monographs 320

    13 Enzymes 357

    Abstract 357

    Section One 358

    13.1 Molecular Characteristics and Therapeutic Applications 358

    13.1.1 Introduction 358

    13.1.2 Enzyme Replacement Therapy 359

    13.1.3 Enzymes as Therapeutic Agents 365

    13.1.4 Summary and Future Prospects 368

    Section Two 370

    13.2 Enzymes Monographs List 370

    13.3 Enzymes Monographs 370

    14 Vaccines (Hu, Ho*) 389

    Abstract 389

    Section One 390

    14.1 Molecular Characteristics and Therapeutic Applications 390

    14.1.1 Vaccines and Their Impact on Human Health 390

    14.1.2 How Vaccines Work: Interplay among Immune System, Diseases, and Vaccines 393

    14.1.3 Traditional Vaccine Approaches 394

    14.1.4 Subcellular and Recombinant Subunit Vaccines 395

    14.1.5 Vaccine Adjuvants 398

    14.1.6 Mode and Route of Vaccine Delivery 400

    14.1.7 Future Directions 403

    14.1.8 Summary 405

    Section Two 409

    14.2 Vaccines Monographs List 409

    14.3 Vaccines Monographs 409

    15 Other Biopharmaceutical Products 417

    Abstract 417

    15.1 Other Biopharmaceutical Products Monographs List 418

    15.2 Other Biopharmaceutical Products Monographs 418

    Part III
    Future Directions 425

    16 Advanced Drug Delivery 427

    Abstract 427

    16.1 Introduction 428

    16.2 Drug Therapeutic Index and Clinical Impact 429

    16.3 Routes of Therapeutic Protein Administration 430

    16.4 Physiological and Mechanistic Approaches 436

    16.5 Approaches Using Devices 458

    16.6 Molecular Approaches 460

    16.7 Summary 465

    17 Advances in Personalized Medicine: Pharmacogenetics in Drug Therapy 471

    Abstract 471

    17.1 Introduction to Interindividual Variation 472

    17.2 Historical Perspective on Pharmacogenetics in Drug Safety and Efficacy 473

    17.3 Pharmacogenetics in Drug Disposition and Pharmacokinetics 478

    17.4 Pharmacogenetics in Drug Effects and Pharmacodynamics 483

    17.5 Individualized Gene-Based Medicine: A Mixed Blessing 487

    17.6 Current and Future Prospects of Pharmacogenetics 490

    17.7 Summary 492

    18 Gene and Cell Therapy 495

    Abstract 495

    18.1 Overview 496

    18.2 General Strategies in Gene and Cell Therapy 499

    18.3 Gene and Cell Therapy for Select Medical Conditions 501

    18.4 Gene Therapy Research, Development, and Clinical Use (Sullivan*) 506

    18.5 Stem Cells in Regenerative Medicine and Diagnostics (Kelly*) 509

    18.6 Summary 513

    19 Integration of Discovery and Development: The Role of Genomics, Proteomics, and Metabolomics 517

    Abstract 517

    19.1 Overview 518

    19.2 Integration of Discovery and Development of Therapeutic Candidates 520

    19.3 Genomics: The First Link between Sequences and Drug Targets 521

    19.4 Proteomics: From Sequences to Functions 524

    19.5 Metabolomics: Metabolic Profile Elucidation 528

    19.6 Integrating Genomic, Proteomic, and Metabolomic Tools to Accelerate Drug Development 530

    19.7 Summary 532

    20 Pharmacoeconomics, Outcome, and Health Technology Assessment Research in Drug Development 535

    Abstract 535

    20.1 Introduction: Health-Care Decisions and Health Outcomes 536

    20.2 Integration of Pharmacoeconomic Outcome Research in Clinical Drug Development 538

    20.3 Regional Differences in the Type of Evidence and Value Data Essential for Health-Care and Reimbursement Decisions 541

    20.4 Biopharmaceutical Company Strategies 542

    20.5 Summary 545

    20.6 Acknowledgments 546

    21 Future Prospects 547

    Abstract 547

    21.1 Progress and Benefits in Transforming Proteins and Genes into Biopharmaceuticals 548

    21.2 Genomic Information Improves Safety and Production Cost of Biopharmaceuticals 548

    21.3 The Business of Biopharmaceuticals and Economic Impacts 549

    21.4 Influence of Biopharmaceuticals on Pharmaceutical Research, Development, and the Drug Industry 549

    21.5 Public-Private Partnership in Financial and Regulatory Support to Improve Translational Success 550

    21.6 Biopharmaceuticals and Public Health Benefits 551

    21.7 Public Participation and Influence on Biopharmaceutical Development 551

    21.8 Outlook 552

    Appendix I. Dosage Form, Pharmacokinetics, and Disposition Data 555

    Appendix II. Molecular Characteristics and Therapeutic Use 581

    Appendix III. Nomenclature of Biotechnology Products 617

    Appendix IV. Other Information 621

    Index 633

    Color plate section is located between pages 210 and 211.