Preparative Chromatography For Separation Of Proteins

The book is divided into three parts: modeling, industrial separations, and case studies. The modeling section will describe the recent developments in chromatographic theory and general approaches to research to obtain increased understanding of the fundamentals behind chromatographic separation and behavior of proteins in that environment. Topics covered include thermodynamic approaches to mechanistic modeling and how it is used to e.g. obtain improved adsorption isotherms, and fundamental descriptions of e.g. protein aggregation and how it may be applied to model the separation behavior. The industrial separations section presents new and existing chromatographic unit operations and how mechanistic and empirical modeling approaches are used to optimize equipment and methodologies. Equipment include column hardware, scale-down equipment, continuous operation mode etc. as well as tools for monitoring and control e.g. on-, in- and at-line equipment for improved process development and manufacturing methods. Improved methodologies comprise scaling approaches, use of models for validation, uncertainty and robustness evaluations, and process design. A mix of industrial, equipment vendor and academic authors contribute to this section. The last section contains case stories from industry on implementation and application of modeling approaches, such as multivariate data analysis, mechanistic modeling for establishment of design space, PAT methods for monitoring and control of chromatographic processes, and on-column refolding.

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 and the author/editor of numerous books including 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.