Process Validation in Manufacturing of Biopharmaceuticals, Third Edition

by Rathore; Anurag S.

• ISBN13: 9781439850930
• ISBN10: 1439850933
• Edition: 3rd
• Format: Hardcover
• Copyright: 2012-05-09
• Publisher: CRC Press

Summary

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.

Table of Contents

Preface	p. ix
Editors	p. xiii
Contributors	p. xv
Guidelines to Process Validation	p. 1
Commentary on the US Food and Drug Administration's 2011 "Guidance for Industry, Process Validation General Principles and Practices"	p. 11
Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes	p. 51
Process Characterization	p. 63
Scaled-Down Models for Purification Processes: Approaches and Applications	p. 89
Adventitious Agents: Concerns and Testing for Biopharmaceuticals	p. 141
Lifespan Studies for Chromatography and Filtration Media	p. 159
Validation of a Filtration Step	p. 185
Analytical Test Methods for Well-Characterized Biological and Biotechnological Products	p. 235
Facility Design Issues: A Regulatory Perspective	p. 269
Validation of Computerized Systems	p. 313
Process Validation with a CMO	p. 355
Risk Management and Validation	p. 375
Process Validation in Membrane Chromatography	p. 385
Leveraging Multivariate Analysis Tools to Qualify Scaled-Down Models	p. 411
Process Validation of a Multivalent Bacterial Vaccine: A Novel Matrix Approach	p. 441
Validation of the Zevalin® Purification Process: A Case Study	p. 455
Viral Clearance Validation: A Case Study	p. 491
Index	p. 503
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