Read more
Informationen zum Autor ARNE STABY is a Fellow and Senior Principal Scientist at Novo Nordisk A/S, Denmark, and the author of numerous papers and presentations in the field. ANURAG S. RATHORE is a Professor in the Department of Chemical Engineering at the Indian Institute of Technology, New Delhi, India. He has published several books that include Quality by Design for Biopharmaceuticals: Principles and Case Studies (Wiley, 2009). SATINDER AHUJA is President of Ahuja Consulting, USA, and the author/editor of numerous books including Chiral Separation Methods for Pharmaceutical and Biotechnological Products (Wiley, 2010), Trace and Ultratrace Analysis by HPLC (Wiley, 1992), and Selectivity and Detectability Optimizations in HPLC (Wiley, 1989). Klappentext Preparative chromatography is a key tool for biopharmaceutical purification for separation of proteins and peptides. Although theory and models have been available for several decades, industrial usage of these tools has been scarce. However, recently implemented quality-by-design (QbD) concepts have led to greater application of modeling in commercial process development and manufacture of proteins and peptides. Written for those biotechnologists, biochemists, pharmaceutical scientists, and engineers working on this aspect of drug development, Preparative Chromatography for Separation of Proteins addresses a wide range of modeling techniques, strategies, and case studies of industrial separation of proteins and peptides. Chapters 1-7 cover basic modeling and reviews, with focus on chromatographic theory developments and research on the fundamentals of chromatographic separation and protein behavior. Chapters 8-18 relate to industrial separations, addressing trends in chromatographic unit operations and how mechanistic and empirical modeling approaches help optimize processes, as well as industrial case histories of various modeling approaches--like multivariate data analysis, design of experiment (DoE), and mechanistic modeling for design space establishment, on-column refolding, and so on. With its unique pairing of academic and industrial perspectives, this book is an indispensable resource for all those involved in the purification of biopharmaceuticals. Zusammenfassung Preparative Chromatography for Separation of Proteins addresses a wide range of the most current modeling techniques! strategies! and case studies of industrial separation of proteins and peptides to aid in the efficiency and efficacy of this broadly-used technique in the purification of biopharmaceuticals. Inhaltsverzeichnis List of Contributors xv Series Preface xix Preface xxi 1 Model?-Based Preparative Chromatography Process Development in the QbD Paradigm 1 Arne Staby, Satinder Ahuja, and Anurag S. Rathore 1.1 Motivation 1 1.2 Regulatory Context of Preparative Chromatography and Process Understanding 1 1.3 Application of Mathematical Modeling to Preparative Chromatography 6 Acknowledgements 8 References 8 2 Adsorption Isotherms: Fundamentals and Modeling Aspects 11 Jørgen M. Mollerup 2.1 Introduction 11 2.2 Definitions 12 2.3 The Solute Velocity Model 14 2.4 Introduction to the Theory of Equilibrium 17 2.5 Association Equilibria 21 2.6 The Classical Adsorption Isotherm 24 2.7 The Classical Ion Exchange Adsorption Isotherm 26 2.8 Hydrophobic Adsorbents, HIC and RPC 38 2.9 Protein-Protein Association and Adsorption Isotherms 47 2.10 The Adsorption Isotherm of a GLP?-1 Analogue 51 2.11 Concluding Remarks 59 Appendix 2.A Classical Thermodynamics 60 References 77 3 Simulation of Process Chromatography 81 Bernt Nilsson and Niklas Andersson 3.1 Introduction ...
