Process Validation in Manufacturing of Biopharmaceuticals
Guidelines, Current Practices, and Industrial Case Studies
2nd Edition
Published on 1. March 2005
Book
Hardback
600 pages
978-1-57444-516-9 (ISBN)
Description
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
Provides specific examples of failure modes and effect analysis (FMEA) that help you establish this method in your organization
More details
Edition
2nd New edition
Language
English
Place of publication
New York
United States
Publishing group
Taylor & Francis Inc
Target group
College/higher education
Professional and scholarly
Biochemists; analytical, medicinal, and biopharmaceutical chemists; biotechnologists; molecular biologists and microbiologists; lab technicians and researchers; and specialists in process development, validation, and quality assurance and control
Edition type
New edition
Product notice
sewn/stitched
Cloth over boards
Illustrations
67 s/w Abbildungen, 75 s/w Tabellen, 2 s/w Photographien bzw. Rasterbilder
2 Halftones, black and white; 75 Tables, black and white; 67 Illustrations, black and white
Dimensions
Height: 235 mm
Width: 157 mm
Thickness: 36 mm
Weight
921 gr
ISBN-13
978-1-57444-516-9 (9781574445169)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
Previous edition
Gail Sofer
Process Validation in Manufacturing of Biopharmaceuticals
Guidelines, Current Practices, and Industrial Case Studies
Book
03/2000
1st Edition
Marcel Dekker Inc
€112.66
Article exhausted; check for reprint
Person
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. Thoemmes
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
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. Thoemmes
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