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 ZEVALINÒ Purification Process - A Case Study, L.
Conley, J. McPherson, and J. Thömmes
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
an extremely timely release that should quickly become a primary reference tool in the pharmaceutical industry.
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