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.

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).