PREPARATIVE CHROMATOGRAPHY FOR SEPARATION OF PROTEINS

1 Model -Based Preparative Chromatography Process Development in the QbD Paradigm 1
2 Adsorption Isotherms: Fundamentals and Modeling Aspects 11
3 Simulation of Process Chromatography 81
4 Simplified Methods Based on Mechanistic Models for Understanding and Designing Chromatography Processes for Proteins and Other Biological Products 111
5 Development of Continuous Capture Steps in Bioprocess Applications 159
6 Computational Modeling in Bioprocess Development 177
7 Chromatographic Scale -Up on a Volume Basis 227
8 Scaling Up Industrial Protein Chromatography: Where Modeling Can Help 247
9 High -Throughput Process Development 269
10 High -Throughput Column Chromatography Performed on Liquid Handling Stations 293
11 Lab -Scale Development of Chromatography Processes 333
12 Problem Solving by Using Modeling 381
13 Modeling Preparative Cation Exchange Chromatography of Monoclonal Antibodies 399
14 Model -Based Process Development in the Biopharmaceutical Industry 429
15 Dynamic Simulations as a Predictive Model for a Multicolumn Chromatography Separation 457
16 Chemometrics Applications in Process Chromatography 479
17 Mid -UV Protein Absorption Spectra and Partial Least Squares Regression as Screening and PAT Tool 501
18 Recent Progress Toward More Sustainable Biomanufacturing: Practical Considerations for Use in the Downstream Processing of Protein Products 537

Preparative Chromatography for Separation of Proteins addresses a wide range of modeling, techniques, strategies, and case studies of industrial separation of proteins and peptides.

• Covers broad aspects of preparative chromatography with a unique combination of academic and industrial perspectives
• Presents Combines modeling with compliantce useing of Quality-by-Design (QbD) approaches including modeling
• Features a variety of chromatographic case studies not readily accessible to the general public
• Represents an essential reference resource for academic, industrial, and pharmaceutical researchers

Author Information
• 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).