Preparative Chromatography for Separation of Proteins

Using preparative chromatography to separate protein and peptides is a key tool for biopharmaceutical purification. Although theory and models have been available for many years, industrial usage of these tools has been scarce. However, the recently implemented Quality by Design (QbD) requirements have lead to greater application in commercial process development and manufacture of protein and peptide separations systems.

Written for those biotechnologists, biochemists, pharmaceutical scientists, and bioengineers 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.

The chapters in the first section cover modeling, with focus on chromatographic theory developments and research on the fundamentals of chromatographic separation and protein behavior. Chapters in the second section relate to industrial separations, addressing trends in chromatographic unit operations and how mechanistic and empirical modeling approaches help optimize equipment and methodologies. In the final section, authors discuss industrial case histories of various modeling approaches like multivariate data analysis, mechanistic modeling for design space, and on–column refolding.

With its unique pairing of academic and industrial perspectives, Preparative Chromatography for Separation of Proteins 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 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, 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. His books include Arsenic Contamination of Groundwater: Mechanism, Analysis, and Remediation; Chiral Separation Methods for Pharmaceutical and Biotechnological Products; Trace and Ultratrace Analysis by HPLC; and Selectivity and Detectability Optimizations in HPLC all published by Wiley.