Fusion Protein Technologies for Biopharmaceuticals

Stefan R. Schmidt 지음

Wiley 2013년 01월 28일 출간

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The state of the art in biopharmaceutical FUSION PROTEIN DESIGNFusion proteins belong to the most lucrative biotech drugs#151;with Enbrel#174; being one of the best#45;selling biologics worldwide. Enbrel#174; represents a milestone of modern therapies just as Humulin#174;, the first therapeutic recombinant protein for human use, approved by the FDA in 1982 and Orthoclone#174; the first monoclonal antibody reaching the market in 1986. These first generation molecules were soon followed by a plethora of recombinant copies of natural human proteins, and in 1998, the first de novo designed fusion protein was launched.Fusion Protein Technologies for Biopharmaceuticals examines the state of the art in developing fusion proteins for biopharmaceuticals, shedding light on the immense potential inherent in fusion protein design and functionality. A wide pantheon of international scientists and researchers deliver a comprehensive and complete overview of therapeutic fusion proteins, combining the success stories of marketed drugs with the dynamic preclinical and clinical research into novel drugs designed for as yet unmet medical needs.The book covers the major types of fusion proteins#151;receptor#45;traps, immunotoxins, Fc#45;fusions and peptibodies#151;while also detailing the approaches for developing, delivering, and improving the stability of fusion proteins. The main body of the book contains three large sections that address issues key to this specialty: strategies for extending the plasma half life, the design of toxic proteins, and utilizing fusion proteins for ultra specific targeting. The book concludes with novel concepts in this field, including examples of highly relevant multifunctional antibodies.Detailing the innovative science, commercial realities, and brilliant potential of fusion protein therapeutics, Fusion Protein Technologies for Biopharmaceuticals is a must for pharmaceutical scientists, biochemists, m

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PREFACE xxiiiCONTRIBUTORS xxvPART I INTRODUCTION 11 Fusion Proteins: Applications and Challenges 3Stefan R. Schmidt1.1 History, 31.2 Definitions and Categories, 41.3 Patenting, 51.4 Design and Engineering, 61.5 Manufacturing, 101.6 Regulatory Challenges, 151.7 Competition and Market, 161.8 Conclusion and Future Perspective, 17References, 182 Analyzing and Forecasting the Fusion Protein Market and Pipeline 25Mark Belsey and Giles Somers2.1 Introduction, 252.2 Market Sales Dynamics of the FP Market, 252.3 Individual Drug Sales Analysis, 272.4 Pipeline Database Analysis, 32Disclaimer, 36Acknowledgment, 36References, 363 Structural Aspects of Fusion Proteins Determining the Level of Commercial Success 39Giles Somers3.1 Classification of FPs, 393.2 Factors for Commercial Success, 49References, 544 Fusion Protein Linkers: Effects on Production, Bioactivity, and Pharmacokinetics 57Xiaoying Chen, Jennica Zaro, and Wei-Chiang Shen4.1 Introduction, 574.2 Overview of General Properties of Linkers Derived From Naturally Occurring Multidomain Proteins, 584.3 Empirical Linkers in Recombinant Fusion Proteins, 594.4 Functionality of Linkers in Fusion Proteins, 664.5 Conclusions and Future Perspective, 70References, 715 Immunogenicity of Therapeutic Fusion Proteins: Contributory Factors and Clinical Experience 75Vibha Jawa, Leslie Cousens, and Anne S. De Groot5.1 Introduction, 755.2 Basis of Therapeutic Protein Immunogenicity, 755.3 Tools for Immunogenicity Screening, 775.4 Approaches for Risk Assessment and Minimization, 815.5 Case Study and Clinical Experience, 835.6 Preclinical and Clinical Immunogenicity Asses

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저자(글) Stefan R. Schmidt

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STEFAN R. SCHMIDT, PhD, is Vice President for Downstream Processing at Rentschler Biotechnology. Previously, he served as CSO at ERA Biotech and Associate Director for Protein Science at AstraZeneca. Dr. Schmidt has chaired many international conferences and written several original articles, reviews, and book chapters.