Process Scale Bioseparations for the Biopharmaceutical Industry
Biotechnology and Bioprocessing Series

The biopharmaceutical industry has become an increasingly important player in the global economy, and the success of these products depends on the development and implementation of cost-effective, robust and scaleable production processes. Bioseparations-also called downstream processing- can be a key source of competitive advantageto biopharmaceutical developers. 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.

Using clear language along with numerous case studies, examples, tables, flow charts, and schematics, the book presents perspectives from experienced professionals involved in purification processes and industrial downstream unit operations. The authors provide useful experimental design strategies and guidelines for developing application-specific process scale bioseparations. Chapter topics include harvest by centrifugation and filtration, expanded bed chromatography, protein refolding, modes of preparative chromatography, methodologies for resin screening, membrane chromatography, protein crystallization, viral filtration, ultrafiltration/diafiltration, implementing post-approval downstream process changes for an antibody product, and future trends.

Ideal for both new and experienced scientists in the biopharmaceutical industry and students, Process Scale Bioseparations for the Biopharmaceutical Industry is a comprehensive resource for all topics relevant to industrial process development.

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. Thömmes
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. Han
A 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. Hubbard
Polishing 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. Yegneswaran, M.G. Gayton, A.L. Lee, N.S. Pujar, M. Perreault, D. Serway, and J. Rozembersky
A Membrane Chromatography Application: A Rapid, High Capacity Gene Therapy Vector Purification Tool; A.R. Lajmi, R. Kutner, and J. Reiser
Index

Abhinav A. Shukla, Mark R. Etzel, Shishir Gadam