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Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs
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 Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies. 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 |
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