{"product_id":"biotechnology-and-biopharmaceuticals-isbn-9781118179796","title":"Biotechnology and Biopharmaceuticals","description":"\u003cp\u003e \u003cb\u003eThe essential single source on drug discovery and biotechnology products—newly revised and updated\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003eSince the first edition of \u003ci\u003eBiotechnology and Biopharmaceuticals \u003c\/i\u003ewas published, biotechnology has continued to drive therapeutic product development. The majority of new medicines coming on the market today are developed based on tools created by biotechnology—and healthcare providers who are concerned with optimum drug therapy need to understand the principles underlying the discovery, development, and application of these biological drugs and therapies of the future.  \u003c\/p\u003e\u003cp\u003e \u003ci\u003eBiotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition \u003c\/i\u003eaddresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics, and cost-effectiveness considerations. It provides research pharmacologists, biopharmaceutical R\u0026amp;D personnel, toxicologists, and biotechnologists with cutting-edge research 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. \u003c\/p\u003e\u003cp\u003e Presented in three parts, and containing several appendices, \u003ci\u003eBiotechnology and Biopharmaceuticals:\u003c\/i\u003e \u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eIntegrates information from pharmacology, biotechnology, and the medical sciences\u003c\/li\u003e \u003cli\u003eCovers the science and art of transforming proteins and genes into drugs\u003c\/li\u003e \u003cli\u003eOffers new coverage of cell-based therapeutics, including stem cells and immune cell therapy\u003c\/li\u003e \u003cli\u003eHighlights the unique applications of biologics, proteins, and macromolecules as therapeutics\u003c\/li\u003e \u003cli\u003eIncludes new chapters on the clinical trial and approval process of individualized medicine\u003c\/li\u003e \u003cli\u003eDiscusses the future direction of the field \u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003e Ideal for research pharmacologists, biopharmaceutical R\u0026amp;D personnel, toxicologists, and biotechnologists, \u003ci\u003eBiotechnology and Biopharmaceuticals \u003c\/i\u003ewill also appeal to clinical pharmacologists, pharmacists, physicians, and health scientists \u003c\/p\u003e\u003cp\u003eContributors xiii\u003c\/p\u003e \u003cp\u003eForeword xv\u003c\/p\u003e \u003cp\u003ePreface xvii\u003c\/p\u003e \u003cp\u003ePreface to the First Edition xix\u003c\/p\u003e \u003cp\u003eAcknowledgments xxi\u003c\/p\u003e \u003cp\u003eOrganization of the Book xxiii\u003c\/p\u003e \u003cp\u003eUser Agreement xxv\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart I\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eTransforming Proteins and Genes into Drugs—The Science and the Art 1\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Introduction to Biopharmaceuticals 3\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eAbstract 3\u003c\/p\u003e \u003cp\u003e1.1 Background and Significance 4\u003c\/p\u003e \u003cp\u003e1.2 Translation of Biotechnology for Developing Biopharmaceuticals 7\u003c\/p\u003e \u003cp\u003e1.3 Historical Perspective of Pharmaceutical Biotechnology 8\u003c\/p\u003e \u003cp\u003e1.4 Distinctions between Chemical Drugs Versus Biopharmaceuticals 8\u003c\/p\u003e \u003cp\u003e1.5 Summary 10\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Distinctions of Biologic Versus Small Molecule Platforms in Drug Development 13\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eAbstract 13\u003c\/p\u003e \u003cp\u003e2.1 Introduction 14\u003c\/p\u003e \u003cp\u003e2.2 Transforming New Molecules into Drugs: The Drug Development Process 14\u003c\/p\u003e \u003cp\u003e2.3 Key Differences between Biotechnology and Chemical Products 16\u003c\/p\u003e \u003cp\u003e2.4 Current Trends in Drug Development 18\u003c\/p\u003e \u003cp\u003e2.5 Summary 22\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Financing Biologic Drug Development 23\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eAbstract 23\u003c\/p\u003e \u003cp\u003e3.1 Introduction 24\u003c\/p\u003e \u003cp\u003e3.2 The Role of the Orphan Drug Act 27\u003c\/p\u003e \u003cp\u003e3.3 Clinical Leverage Strategy in Accelerating Drug Development 30\u003c\/p\u003e \u003cp\u003e3.4 Therapeutic Target Considerations 32\u003c\/p\u003e \u003cp\u003e3.5 Evolving Trends 34\u003c\/p\u003e \u003cp\u003e3.6 Summary 36\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Application of Biotechnology in Drug Discovery and Early Development 39\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eAbstract 39\u003c\/p\u003e \u003cp\u003e4.1 Introduction 40\u003c\/p\u003e \u003cp\u003e4.2 Data Mining, Molecular Cloning, and Characterization 40\u003c\/p\u003e \u003cp\u003e4.3 Optimization of Cell Expression Systems and Product Yield 50\u003c\/p\u003e \u003cp\u003e4.4 Molecular Optimization 51\u003c\/p\u003e \u003cp\u003e4.5 Proteins and Genes as Targets for Drug Discovery and Development 56\u003c\/p\u003e \u003cp\u003e4.6 Summary 58\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Large-Scale Production of Recombinant Proteins 63\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eAbstract 63\u003c\/p\u003e \u003cp\u003e5.1 Introduction 64\u003c\/p\u003e \u003cp\u003e5.2 Yield Optimization in Genetic Constructs and Host Cells 65\u003c\/p\u003e \u003cp\u003e5.3 Large-Scale Cultivation of Host Cells 66\u003c\/p\u003e \u003cp\u003e5.4 Downstream Processing and Purification 70\u003c\/p\u003e \u003cp\u003e5.5 Quality Assurance and Quality Control 75\u003c\/p\u003e \u003cp\u003e5.6 Summary 77\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Clinical Pharmacology, Toxicology, and Therapeutic Dosage and Response 79\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eAbstract 79\u003c\/p\u003e \u003cp\u003e6.1 Introduction 80\u003c\/p\u003e \u003cp\u003e6.2 Clinical Pharmacology and Toxicology 80\u003c\/p\u003e \u003cp\u003e6.3 Dose and Therapeutic Response 95\u003c\/p\u003e \u003cp\u003e6.4 Dosage Form and Route of Administration 97\u003c\/p\u003e \u003cp\u003e6.5 Summary 99\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Clinical Evaluation and Regulatory Approval and Enforcement of Biopharmaceuticals 103\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eAbstract 103\u003c\/p\u003e \u003cp\u003e7.1 Introduction: Biologic Drug Development and Approval 104\u003c\/p\u003e \u003cp\u003e7.2 Licensing of Biological Products 104\u003c\/p\u003e \u003cp\u003e7.3 Preclinical and Clinical Testing 107\u003c\/p\u003e \u003cp\u003e7.4 FDA Review and Approval Process 114\u003c\/p\u003e \u003cp\u003e7.5 Regulatory Enforcement 118\u003c\/p\u003e \u003cp\u003e7.6 Globalization of Drug Approval (Chien*) 118\u003c\/p\u003e \u003cp\u003e7.7 Summary 122\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Pharmacoeconomics and Drug Pricing (Garrison*) 125\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eAbstract 125\u003c\/p\u003e \u003cp\u003e8.1 Introduction: Pharmacoeconomics 126\u003c\/p\u003e \u003cp\u003e8.2 Cost-Effectiveness: Assessing the Value of Biopharmaceuticals 126\u003c\/p\u003e \u003cp\u003e8.3 The Cost of Developing Biopharmaceuticals 128\u003c\/p\u003e \u003cp\u003e8.4 Pricing Biopharmaceuticals 131\u003c\/p\u003e \u003cp\u003e8.5 Drug Development Incentives 133\u003c\/p\u003e \u003cp\u003e8.6 Economics of Biosimilars 133\u003c\/p\u003e \u003cp\u003e8.7 Economic Impact of Personalized Medicine 134\u003c\/p\u003e \u003cp\u003e8.8 Summary and Future Challenges 135\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart II\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eTherapeutic and Clinical Applications of Biopharmaceuticals— Proteins and Nucleic Acids 137\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Antibodies and Derivatives 139\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eAbstract 139\u003c\/p\u003e \u003cp\u003eSection One 140\u003c\/p\u003e \u003cp\u003e9.1 Molecular Characteristics and Therapeutic Applications 140\u003c\/p\u003e \u003cp\u003e9.1.1 Introduction 140\u003c\/p\u003e \u003cp\u003e9.1.2 Historical Perspective—Discovery, Classification, Biodistribution, and Physiological Characteristics of Antibody Molecules 140\u003c\/p\u003e \u003cp\u003e9.1.3 Gamma Globulin and Hyperimmune Globulin 144\u003c\/p\u003e \u003cp\u003e9.1.4 Monoclonal Antibodies—From Mouse, Mouse-Human Chimeric, Humanized, to Human Monoclonal Antibodies 145\u003c\/p\u003e \u003cp\u003e9.1.5 Antibody Derivatives 147\u003c\/p\u003e \u003cp\u003e9.1.6 Disposition of Antibodies 149\u003c\/p\u003e \u003cp\u003e9.1.7 Extravascular Tissue Penetration 155\u003c\/p\u003e \u003cp\u003e9.1.8 Mechanisms of Antibody Bioactivities 156\u003c\/p\u003e \u003cp\u003e9.1.9 Antibody Conjugates 156\u003c\/p\u003e \u003cp\u003e9.1.10 Antibodies and Derivatives in Development 158\u003c\/p\u003e \u003cp\u003e9.1.11 Summary 159\u003c\/p\u003e \u003cp\u003eSection Two 162\u003c\/p\u003e \u003cp\u003e9.2 Antibodies and Derivatives Monographs List 162\u003c\/p\u003e \u003cp\u003e9.3 Antibodies and Derivatives Monographs 163\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Hematopoietic Growth and Coagulation Factors 211\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eAbstract 211\u003c\/p\u003e \u003cp\u003eSection One 212\u003c\/p\u003e \u003cp\u003e10.1 Molecular Characteristics and Therapeutic Applications 212\u003c\/p\u003e \u003cp\u003e10.1.1 Introduction 212\u003c\/p\u003e \u003cp\u003e10.1.2 Hematopoietic Growth and Coagulation Factors 212\u003c\/p\u003e \u003cp\u003e10.1.3 Therapeutic Use of Hematopoietic Growth Factors (Molineux, Elliott*) 218\u003c\/p\u003e \u003cp\u003e10.1.4 Therapeutic Use of Coagulation and Anticoagulation Factors 225\u003c\/p\u003e \u003cp\u003e10.1.5 Summary 229\u003c\/p\u003e \u003cp\u003eSection Two 231\u003c\/p\u003e \u003cp\u003e10.2 Hematopoietic Growth and Coagulation Factors List 231\u003c\/p\u003e \u003cp\u003e10.3 Hematopoietic Growth and Coagulation Factors Monographs 231\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Cytokines and Interferons 251\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eAbstract 251\u003c\/p\u003e \u003cp\u003eSection One 252\u003c\/p\u003e \u003cp\u003e11.1 Molecular Characteristics and Therapeutic Applications 252\u003c\/p\u003e \u003cp\u003e11.1.1 Introduction 252\u003c\/p\u003e \u003cp\u003e11.1.2 Interleukins as Immunotherapeutics 252\u003c\/p\u003e \u003cp\u003e11.1.3 Interferon Biology and Cancer Therapy (Tiu, Koon, Borden*) 256\u003c\/p\u003e \u003cp\u003e11.1.4 Interferons as Antiviral Therapy 271\u003c\/p\u003e \u003cp\u003e11.1.5 Interferons in Multiple Sclerosis 275\u003c\/p\u003e \u003cp\u003e11.1.6 Summary 280\u003c\/p\u003e \u003cp\u003eSection Two 288\u003c\/p\u003e \u003cp\u003e11.2 Cytokines and Interferons Monographs List 288\u003c\/p\u003e \u003cp\u003e11.3 Cytokines and Interferons Monographs 288\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Hormones 307\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eAbstract 307\u003c\/p\u003e \u003cp\u003eSection One 308\u003c\/p\u003e \u003cp\u003e12.1 Molecular Characteristics and Therapeutic Applications 308\u003c\/p\u003e \u003cp\u003e12.1.1 Introduction 308\u003c\/p\u003e \u003cp\u003e12.1.2 Peptide Hormones and Clinical Significance 308\u003c\/p\u003e \u003cp\u003e12.1.3 Therapeutic Application of Recombinant and Synthetic Hormones 309\u003c\/p\u003e \u003cp\u003e12.1.4 Summary 318\u003c\/p\u003e \u003cp\u003eSection Two 320\u003c\/p\u003e \u003cp\u003e12.2 Hormones Monographs List 320\u003c\/p\u003e \u003cp\u003e12.3 Hormones Monographs 320\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Enzymes 357\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eAbstract 357\u003c\/p\u003e \u003cp\u003eSection One 358\u003c\/p\u003e \u003cp\u003e13.1 Molecular Characteristics and Therapeutic Applications 358\u003c\/p\u003e \u003cp\u003e13.1.1 Introduction 358\u003c\/p\u003e \u003cp\u003e13.1.2 Enzyme Replacement Therapy 359\u003c\/p\u003e \u003cp\u003e13.1.3 Enzymes as Therapeutic Agents 365\u003c\/p\u003e \u003cp\u003e13.1.4 Summary and Future Prospects 368\u003c\/p\u003e \u003cp\u003eSection Two 370\u003c\/p\u003e \u003cp\u003e13.2 Enzymes Monographs List 370\u003c\/p\u003e \u003cp\u003e13.3 Enzymes Monographs 370\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Vaccines (Hu, Ho*) 389\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eAbstract 389\u003c\/p\u003e \u003cp\u003eSection One 390\u003c\/p\u003e \u003cp\u003e14.1 Molecular Characteristics and Therapeutic Applications 390\u003c\/p\u003e \u003cp\u003e14.1.1 Vaccines and Their Impact on Human Health 390\u003c\/p\u003e \u003cp\u003e14.1.2 How Vaccines Work: Interplay among Immune System, Diseases, and Vaccines 393\u003c\/p\u003e \u003cp\u003e14.1.3 Traditional Vaccine Approaches 394\u003c\/p\u003e \u003cp\u003e14.1.4 Subcellular and Recombinant Subunit Vaccines 395\u003c\/p\u003e \u003cp\u003e14.1.5 Vaccine Adjuvants 398\u003c\/p\u003e \u003cp\u003e14.1.6 Mode and Route of Vaccine Delivery 400\u003c\/p\u003e \u003cp\u003e14.1.7 Future Directions 403\u003c\/p\u003e \u003cp\u003e14.1.8 Summary 405\u003c\/p\u003e \u003cp\u003eSection Two 409\u003c\/p\u003e \u003cp\u003e14.2 Vaccines Monographs List 409\u003c\/p\u003e \u003cp\u003e14.3 Vaccines Monographs 409\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 Other Biopharmaceutical Products 417\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eAbstract 417\u003c\/p\u003e \u003cp\u003e15.1 Other Biopharmaceutical Products Monographs List 418\u003c\/p\u003e \u003cp\u003e15.2 Other Biopharmaceutical Products Monographs 418\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart III\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eFuture Directions 425\u003c\/p\u003e \u003cp\u003e\u003cb\u003e16 Advanced Drug Delivery 427\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eAbstract 427\u003c\/p\u003e \u003cp\u003e16.1 Introduction 428\u003c\/p\u003e \u003cp\u003e16.2 Drug Therapeutic Index and Clinical Impact 429\u003c\/p\u003e \u003cp\u003e16.3 Routes of Therapeutic Protein Administration 430\u003c\/p\u003e \u003cp\u003e16.4 Physiological and Mechanistic Approaches 436\u003c\/p\u003e \u003cp\u003e16.5 Approaches Using Devices 458\u003c\/p\u003e \u003cp\u003e16.6 Molecular Approaches 460\u003c\/p\u003e \u003cp\u003e16.7 Summary 465\u003c\/p\u003e \u003cp\u003e\u003cb\u003e17 Advances in Personalized Medicine: Pharmacogenetics in Drug Therapy 471\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eAbstract 471\u003c\/p\u003e \u003cp\u003e17.1 Introduction to Interindividual Variation 472\u003c\/p\u003e \u003cp\u003e17.2 Historical Perspective on Pharmacogenetics in Drug Safety and Efficacy 473\u003c\/p\u003e \u003cp\u003e17.3 Pharmacogenetics in Drug Disposition and Pharmacokinetics 478\u003c\/p\u003e \u003cp\u003e17.4 Pharmacogenetics in Drug Effects and Pharmacodynamics 483\u003c\/p\u003e \u003cp\u003e17.5 Individualized Gene-Based Medicine: A Mixed Blessing 487\u003c\/p\u003e \u003cp\u003e17.6 Current and Future Prospects of Pharmacogenetics 490\u003c\/p\u003e \u003cp\u003e17.7 Summary 492\u003c\/p\u003e \u003cp\u003e\u003cb\u003e18 Gene and Cell Therapy 495\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eAbstract 495\u003c\/p\u003e \u003cp\u003e18.1 Overview 496\u003c\/p\u003e \u003cp\u003e18.2 General Strategies in Gene and Cell Therapy 499\u003c\/p\u003e \u003cp\u003e18.3 Gene and Cell Therapy for Select Medical Conditions 501\u003c\/p\u003e \u003cp\u003e18.4 Gene Therapy Research, Development, and Clinical Use (Sullivan*) 506\u003c\/p\u003e \u003cp\u003e18.5 Stem Cells in Regenerative Medicine and Diagnostics (Kelly*) 509\u003c\/p\u003e \u003cp\u003e18.6 Summary 513\u003c\/p\u003e \u003cp\u003e\u003cb\u003e19 Integration of Discovery and Development: The Role of Genomics, Proteomics, and Metabolomics 517\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eAbstract 517\u003c\/p\u003e \u003cp\u003e19.1 Overview 518\u003c\/p\u003e \u003cp\u003e19.2 Integration of Discovery and Development of Therapeutic Candidates 520\u003c\/p\u003e \u003cp\u003e19.3 Genomics: The First Link between Sequences and Drug Targets 521\u003c\/p\u003e \u003cp\u003e19.4 Proteomics: From Sequences to Functions 524\u003c\/p\u003e \u003cp\u003e19.5 Metabolomics: Metabolic Profile Elucidation 528\u003c\/p\u003e \u003cp\u003e19.6 Integrating Genomic, Proteomic, and Metabolomic Tools to Accelerate Drug Development 530\u003c\/p\u003e \u003cp\u003e19.7 Summary 532\u003c\/p\u003e \u003cp\u003e\u003cb\u003e20 Pharmacoeconomics, Outcome, and Health Technology Assessment Research in Drug Development 535\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eAbstract 535\u003c\/p\u003e \u003cp\u003e20.1 Introduction: Health-Care Decisions and Health Outcomes 536\u003c\/p\u003e \u003cp\u003e20.2 Integration of Pharmacoeconomic Outcome Research in Clinical Drug Development 538\u003c\/p\u003e \u003cp\u003e20.3 Regional Differences in the Type of Evidence and Value Data Essential for Health-Care and Reimbursement Decisions 541\u003c\/p\u003e \u003cp\u003e20.4 Biopharmaceutical Company Strategies 542\u003c\/p\u003e \u003cp\u003e20.5 Summary 545\u003c\/p\u003e \u003cp\u003e20.6 Acknowledgments 546\u003c\/p\u003e \u003cp\u003e\u003cb\u003e21 Future Prospects 547\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eAbstract 547\u003c\/p\u003e \u003cp\u003e21.1 Progress and Benefits in Transforming Proteins and Genes into Biopharmaceuticals 548\u003c\/p\u003e \u003cp\u003e21.2 Genomic Information Improves Safety and Production Cost of Biopharmaceuticals 548\u003c\/p\u003e \u003cp\u003e21.3 The Business of Biopharmaceuticals and Economic Impacts 549\u003c\/p\u003e \u003cp\u003e21.4 Influence of Biopharmaceuticals on Pharmaceutical Research, Development, and the Drug Industry 549\u003c\/p\u003e \u003cp\u003e21.5 Public–Private Partnership in Financial and Regulatory Support to Improve Translational Success 550\u003c\/p\u003e \u003cp\u003e21.6 Biopharmaceuticals and Public Health Benefits 551\u003c\/p\u003e \u003cp\u003e21.7 Public Participation and Influence on Biopharmaceutical Development 551\u003c\/p\u003e \u003cp\u003e21.8 Outlook 552\u003c\/p\u003e \u003cp\u003eAppendix I. Dosage Form, Pharmacokinetics, and Disposition Data 555\u003c\/p\u003e \u003cp\u003eAppendix II. Molecular Characteristics and Therapeutic Use 581\u003c\/p\u003e \u003cp\u003eAppendix III. Nomenclature of Biotechnology Products 617\u003c\/p\u003e \u003cp\u003eAppendix IV. Other Information 621\u003c\/p\u003e \u003cp\u003eIndex 633\u003c\/p\u003e \u003cp\u003eColor plate section is located between pages 210 and 211.\u003c\/p\u003e  \u003cp\u003e“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.”  (\u003ci\u003eClinical Infectious Diseases\u003c\/i\u003e, 30 October 2014)\u003c\/p\u003e  \u003cp\u003e \u003cb\u003eThe essential single source on drug discovery and biotechnology products—newly revised and updated\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003eSince the first edition of \u003ci\u003eBiotechnology and Biopharmaceuticals \u003c\/i\u003ewas published, biotechnology has continued to drive therapeutic product development. The majority of new medicines coming on the market today are developed based on tools created by biotechnology—and healthcare providers who are concerned with optimum drug therapy need to understand the principles underlying the discovery, development, and application of these biological drugs and therapies of the future.  \u003c\/p\u003e\u003cp\u003e \u003ci\u003eBiotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition \u003c\/i\u003eaddresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics, and cost-effectiveness considerations. It provides research pharmacologists, biopharmaceutical R\u0026amp;D personnel, toxicologists, and biotechnologists with cutting-edge research 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. \u003c\/p\u003e\u003cp\u003e Presented in three parts, and containing several appendices, \u003ci\u003eBiotechnology and Biopharmaceuticals:\u003c\/i\u003e \u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eIntegrates information from pharmacology, biotechnology, and the medical sciences\u003c\/li\u003e \u003cli\u003eCovers the science and art of transforming proteins and genes into drugs\u003c\/li\u003e \u003cli\u003eOffers new coverage of cell-based therapeutics, including stem cells and immune cell therapy\u003c\/li\u003e \u003cli\u003eHighlights the unique applications of biologics, proteins, and macromolecules as therapeutics\u003c\/li\u003e \u003cli\u003eIncludes new chapters on the clinical trial and approval process of individualized medicine\u003c\/li\u003e \u003cli\u003eDiscusses the future direction of the field \u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003e Ideal for research pharmacologists, biopharmaceutical R\u0026amp;D personnel, toxicologists, and biotechnologists, \u003ci\u003eBiotechnology and Biopharmaceuticals \u003c\/i\u003ewill also appeal to clinical pharmacologists, pharmacists, physicians, and health scientists\u003c\/p\u003e","brand":"Wiley-Blackwell","offers":[{"title":"Default Title","offer_id":47988842889445,"sku":"NP9781118179796","price":179.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781118179796.jpg?v=1761781739","url":"https:\/\/k12savings.com\/es\/products\/biotechnology-and-biopharmaceuticals-isbn-9781118179796","provider":"K12savings","version":"1.0","type":"link"}