Process validation in manufacturing of biopharmaceuticals : guidelines, current practices, and industrial case studies

Content: Guidelines to Process Validation, G. Sofer Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes, R.J. Seely and J. Haury Process Characterization, J.E. Seely Scale-Down Models for Purification Processes: Approaches and Applications, R. Godavarti, J. Petrone, J. Robinson, R. Wright, and B.D. Kelley Adventitious Agents: Concerns and Testing for Biopharmaceuticals, R. Nims, E. Presente, G. Sofer, C. Phillips, and A. Chang Life Span Studies for Chromatography and Filtration Media, A.S. Rathore and G. Sofer Validation of a Flitration Strap, J. Campbell Analytical Test Methods for Well-Characterized Biological and Biotechnological Products, N. Ritter and J. McEntire Facility Design Issues-A Regulatory Perspective, N. Roscioli and S. Vargo Validation of Computerized Systems, M.J. Cahilly Process Optimization and Characterization Studies for Purification of an E. coli-Expressed Protein Product, A.S. Rathore Validation of the ZEVALINO Purification Process - A Case Study, L. Conley, J. McPherson, and J. Thommes Process Validation of a Multivalent Bacterial Vaccine: A Novel Matrix Approach, N.S. Pujar, M.G. Gayton, W.K. Herber, C. Abeygunawardana, M.L. Dekleva, P.K. Yegneswaran, and A.L. Lee Viral Clearance Validation: A Case Study, M. Rubino, M. Bailey, J. Baker, J.A. Boose, L. Metzka, V. Moore, M. Quertinmont, and W. Wiler about the editors... ANURAG S. RATHORE is a Scientist in Process Development, Amgen Inc., Thousand Oaks, California. His group is responsible for the support of process development, process characterization, scale-up, production, and process validation of late stage products. Before joining Amgen Inc., he held a similar position at Pharmacia Corporation. Dr. Rathore has authored more than 50 publications and presentations and is series editor of the Biotechnology and Bioprocessing series for Marcel Dekker. He is the editor of several recent books including Scale-up