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Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies
Edited by Anurag Singh Rathore; Gail Sofer
CRC Press
2005
Hardback 600 pp ISBN 978 157 444 5169
£115.00
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This guide contains
- Process characterization and techniques for scaling-down unit operations that are commonly used
in biopharmaceutical manufacturing
- Guidance on determination of lifespan of chromatography and filtration media
- A chapter on facility design and inspection by a former FDA official-including sections on license
application, utilities, cleaning, and environmental monitoring, as well as issues specific to multi-product facilities
- Discussion of computerized system compliance
- Examples of contamination events, as well as tables describing adventitious agents and recommended
testing programs
- Practical methods to test raw materials and in-process samples during various manufacturing stages
- Case studies highlighting validation approaches successfully taken in the industry
- Coverage of topics such as scale-down modeling, process characterization, FMEA, PAT, and facility
design issues sets this book a apart form other books available on this topic. Exploring a wide spectrum of topics,
the book is suitable as a reference for newcomers to the field and provides useful examples to seasoned professionals.
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
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 ZEVALINO 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
To find similar publications, click on a keyword below:
CRC Press
: analytical methods
: bioproducts
: guidelines
: licencing
: pharmaceuticals
: process validation
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