Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs

Overview

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 ...

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Overview

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.

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Editorial Reviews

From the Publisher
“...a useful book for a...class in the pharmacology and pharmacokinetics of biotechnology-derived products, as well as a good introductory book for people new to the biotechnology industry.” (Pharmaceutical Research, Vol. 20, No. 12, December 2003)
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Product Details

  • ISBN-13: 9781118179796
  • Publisher: Wiley
  • Publication date: 10/28/2013
  • Edition description: New Edition
  • Edition number: 2
  • Pages: 744
  • Product dimensions: 8.50 (w) x 10.90 (h) x 1.20 (d)

Meet the Author

Active individual and professional traders.

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Table of Contents

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.

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