Using clear language along with numerous case studies, examples, tables, flow charts, and schematics Process Scale Bioseparations for the Biopharmaceutical Industry brings together scientific principles, empirical approaches, and practical considerations for designing industrial downstream bioprocesses for various classes of biomolecules. Experienced professionals in purification processes and industrial downstream unit operations provide useful experimental design strategies and guidelines for developing application-specific process scale bioseparations. They also consider analytical methods, viral validation, regulatory aspects, and emerging areas such as high gradient magnetic fishing for capture.

Harvest of a Therapeutic Protein Product from High Cell Density Fermentation Broths: Principles and Case Study; E. Russell, A. Wang, and A.S. Rathore Expanded Bed Adsorption for Capture from Crude Solution; A. Sonnenfeld and J. Thommes Product Recovery by High-Gradient Magnetic Fishing; M. Franzreb, N. Ebner, M. Siemann-Herzberg, T.J. Hobley, and O.R.T. Thomas Protein Refolding and Scale Up; C. Cowgill, A. Ozturk, and R. St. John Bulk Protein Crystallization-Principles and Methods; M.R. Etzel Modes of Preparative Chromatography; A.A. Shukla and Y. Yigzaw Screening of Chromatographic Stationary Phases; A.A. Shukla and X.S. HanA Priori Prediction of Chromatographic Separations from Protein Structure Data; A. Ladiwala, C.M. Breneman, and S.M. Cramer Membrane Chromatography: Analysis of Breakthrough Curves and Viral Clearance; M.R. Etzel and W.T. Riordan Ultrafiltration Process Design and Implementation; H. Lutz and B. Raghunath Virus Filtration Process Design and Implementation; M.W. Phillips, G. Bolton, M. Krishnan, J.J. Lewnard, and B. Raghunath Product Recovery from Transgenic Sources; C. Zhang and K.E. Van Cott Analytical Strategy for Biopharmaceutical Development; D.N. Kelner and M.K. Bhalgat Evaluation of Viral Clearance in Purification Processes; A. Kundu and K. Reindel Advances in Viral Clearance; K. Brorson Protein A Affinity Chromatography for Capture and Purification of Monoclonal Antibodies and Fc-Fusion Proteins: Practical Considerations for Process Development; S. Ghose , T. McNerney, and B. HubbardPolishing Methods for Monoclonal IgG Purification; P. Gagnon Making Changes to a Biopharmaceutical Manufacturing Process During Development and Commercial Manufacturing: The REMICADE Story; P.W. Wojciechowski, H.I. Smit, M.M. Myers, P.J. Voronko, T. Laverty, R. A. Ramelmeier, and R.C. Siegel Linear Scale-Up of Ultrafiltration of High Viscosity Process Streams; C. Daniels, B. Gierl, P.K