Process Validation in Manufacturing of Biopharmaceuticals

ISBN-10: 1439850933
ISBN-13: 9781439850930
Edition: 3rd 2012 (Revised)
List price: $327.00 Buy it from $122.95
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Description: Written by experienced authorities in process validation, this book explores strategies for selecting the most appropriate quality control processes. It offers practical guidelines, recommendations, and an abundance of industrial case studies that  More...

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Book details

List price: $327.00
Edition: 3rd
Copyright year: 2012
Publisher: CRC Press LLC
Publication date: 5/9/2012
Binding: Hardcover
Pages: 532
Size: 6.25" wide x 9.50" long x 1.25" tall
Weight: 1.936
Language: English

Written by experienced authorities in process validation, this book explores strategies for selecting the most appropriate quality control processes. It offers practical guidelines, recommendations, and an abundance of industrial case studies that demonstrate various techniques and approaches in the validation of biopharmaceutica1 processes. This third edition of the text addresses the numerous changes made in the pharmaceutical industry as well as the many modifications that have been made to regulations. In addition, the authors also cover advances in biotechnology. Each chapter has been thoroughly updated.

#60;p#62;Anurag S. Rathore received his PhD in chemical engineering from Yale University and is the Director of Process Development, Amgen Inc. His areas of interest include process development, scale-up, technology transfer, process validation, process analytical technology, and quality by design. He has authored more than 100 publications and presentations in these areas and serves on the editorial advisory boards for Biotechnology Progress, BioPharm International, Pharmaceutical Technology Europe, Journal of Biochemical and Biophysical Methods, and Separation and Purification Reviews.#60;/p#62;#60;p#62;Rohin Mhatre is a Senior Director in the BioProcess Development department at Biogen Idec, Cambridge, Massachusetts, and has been with the company since 1996. His group is responsible for development of analytical methods and product characterization to support the process and formulation development of early and late stage clinical programs. Mhatre is also leading the QbD initiative within Biogen Idec. He has authored several publications and been an invited speaker to numerous scientific meetings.#62;/p#62;

Lars Hagel is a Ph.D. in analytical chemistry and also Associate Professor at the University of Uppsala. Dr. Hagel has held different management positions within the R&D department and is now a senior scientific consultant of Pharmacia Biotech. He is a member of the board for The Swedish Centre for Bioseparations, and he chairs the Centre for Bioprocess Technology. Dr. Hagel's research has focused upon practical implications of chromatography theory and he has published a vast number of papers and chapters, with special reference to gel filtration. Gail Sofer has been consulting with biotechnology and pharmaceutical companies for the past five years through the Fast Trak Validation(r) group of PharmaciaBiotech as the Director of International Validation Development. A series of publications on validation have provided guidance to many in this arena. She is active in organizations such as PDA and ASTM.

Preface
Editors
Contributors
Guidelines to Process Validation
Commentary on the US Food and Drug Administration's 2011 "Guidance for Industry, Process Validation General Principles and Practices"
Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes
Process Characterization
Scaled-Down Models for Purification Processes: Approaches and Applications
Adventitious Agents: Concerns and Testing for Biopharmaceuticals
Lifespan Studies for Chromatography and Filtration Media
Validation of a Filtration Step
Analytical Test Methods for Well-Characterized Biological and Biotechnological Products
Facility Design Issues: A Regulatory Perspective
Validation of Computerized Systems
Process Validation with a CMO
Risk Management and Validation
Process Validation in Membrane Chromatography
Leveraging Multivariate Analysis Tools to Qualify Scaled-Down Models
Process Validation of a Multivalent Bacterial Vaccine: A Novel Matrix Approach
Validation of the Zevalin� Purification Process: A Case Study
Viral Clearance Validation: A Case Study
Index

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