Process Validation in Manufacturing Biopharmaceuticals Guidelines Current Practices and Industrial Case Studies Second Edition by Gail Sofer ISBN 1574445162 978-1574445169
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Product details:
ISBN 10: 1574445162
ISBN 13: 978-1574445169
Author: Gail Sofer
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
Table of contents:
1 Guidelines to Process Validation
Gail Sofer
2 Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes
Robert J. Seely and John Haury
3 Process Characterization
James E. Seely
4 Scale-Down Models for Purification Processes: Approaches and Applications
Ranga Godavarti, Jon Petrone, Jeff Robinson, Richard Wright, and Brian D. Kelley
5 Adventitious Agents: Concerns and Testing for Biopharmaceuticals
Ray Nims, Esther Presente, Gail Sofer, Carolyn Phillips, and Audrey Chang
6 Life Span Studies for Chromatography and Filtration Media
Anurag S. Rathore and Gail Sofer
7 Validation of a Filtration Step
Jennifer Campbell
8 Analytical Test Methods for Biological and Biotechnological Products
Nadine Ritter and John McEntire
9 Facility Design Issues — A Regulatory Perspective
Nancy Roscioli and Susan Vargo
10 Validation of Computerized Systems
Monica J. Cahilly
11 Process Optimization and Characterization Studies for Purification of an E. coli-Expressed Protein Product
Anurag S. Rathore
12 Validation of the ZEVALIN® Purification Process — A Case Study
Lynn Conley, John McPherson, and Jörg Thömmes
Chapter 13
Process Validation of a Multivalent Bacterial Vaccine:
A Novel Matrix Approach
Narahari S. Pujar, Marshall G. Gayton, Wayne K. Herber,
Chitrananda Abeygunawardana, Michael L. Dekleva,
P. K. Yegneswaran, and Ann L. Lee
Chapter 14
Viral Clearance Validation: A Case Study
Michael Rubino, Mark Bailey, Jeffrey C. Baker,
Jeri Ann Boose, Lorraine Metzka, Valerie Moore,
Michelle Quertinmont, and William Wiler
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Tags: Gail Sofer, Process Validation, Manufacturing Biopharmaceuticals, Current Practices