Preparative Chromatography for Separation of Proteins

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.