Process Validation in Manufacturing of Biopharmaceuticals, Second Edition: Guidelines, Current Practices, and Industrial Case Studies / Edition 2

by Gail Sofer, Rathore Singh Rathore

Overview

Written by experienced authorities in process validation, Process Validation in Manufacturing of Biopharmaceuticals explores current trends in the field and strategies for the selection of the most appropriate quality control scheme. It offers practical guidelines, recommendations, and an abundance of industrial case studies that demonstrate various techniques and approaches in the validation of biopharmaceutical processes.

Provides specific examples of failure modes and effect analysis (FMEA) that help you establish this method in your organization

Product Details

ISBN-13:	9781574445169
Publisher:	Taylor & Francis
Publication date:	04/27/2005
Series:	Biotechnology and Bioprocessing Series , #29
Edition description:	REV
Pages:	600
Product dimensions:	6.20(w) x 9.10(h) x 1.50(d)

Table of Contents

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