Biotechnology and Biopharmaceuticals - Transforming Proteins and Genes Into Drugs

Informationen zum Autor Rodney Ho is a Milo Gibaldi Endowed Professor at the University of Washington School of Pharmacy in Seattle. He is founder and principal scientist of Impel NeuroPharma and Nova Theranostics, as well as a visiting professor at the School of Chemical Biology and Biotechnology at Peking University. Dr. Ho co-edited the first edition of "Biotechnology and Biopharmaceuticals", and has served in an editorial capacity for?numerous journals including J. of Pharmaceutical Sciences, Frontiers in Biosciences, and Open Journal: Clinical Medicine: Blood Disorders. Klappentext The essential single source on drug discovery and biotechnology products-newly revised and updated Since the first edition of Biotechnology and Biopharmaceuticals was 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. 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. It provides research pharmacologists, biopharmaceutical R&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. Presented in three parts, and containing several appendices, Biotechnology and Biopharmaceuticals: Integrates information from pharmacology, biotechnology, and the medical sciences Covers the science and art of transforming proteins and genes into drugs Offers new coverage of cell-based therapeutics, including stem cells and immune cell therapy Highlights the unique applications of biologics, proteins, and macromolecules as therapeutics Includes new chapters on the clinical trial and approval process of individualized medicine Discusses the future direction of the field Ideal for research pharmacologists, biopharmaceutical R&D personnel, toxicologists, and biotechnologists, Biotechnology and Biopharmaceuticals will also appeal to clinical pharmacologists, pharmacists, physicians, and health scientists Zusammenfassung The essential single source on drug discovery and biotechnology products, Biotechnology and Biopharmaceuticals addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics, and cost-effectiveness considerations. Inhaltsverzeichnis 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...

List 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

Report

"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)

Product details

• Authors: Milo Gibaldi, Ho, RJY Ho, Rodney J Y Ho, Rodney J. Y. Ho, Rodney J. Y. Gibaldi Ho
• Publisher: Wiley, John and Sons Ltd
• Languages: English
• Product format: Paperback / Softback
• Released: 22.11.2013
• EAN: 9781118179796
• ISBN: 978-1-118-17979-6
• No. of pages: 736
• Subjects: Natural sciences, medicine, IT, technology > Biology > Genetics, genetic engineering; Chemie, Biotechnologie, Life Sciences, Biowissenschaften, biotechnology, chemistry, MEDIZINISCHE CHEMIE, Biomedical engineering, Pharmazeutische Medizin, Biotechnologie i. d. Biowissenschaften, Biomedizintechnik, Biopharmazeutika u. Pharmazeutische Biotechnologie, Biopharmaceuticals & Pharmaceutical Biotechnology, Molekulares Bioengineering, Molecular Bioengineering