Process Validation in Manufacturing of Biopharmaceuticals

Anurag Singh Rathore, Hal Baseman, Scott Rudge, Anurag Singh Rathore, Hal Baseman, Scott Rudge

• Publisher: CRC Press
• Year: 2023
• Print ISBN: 9780367697624
• eBook ISBN: 9781003805472
• Edition: 4
• Topic: Medicine
• Subtopic: Biotechnology

The fourth edition of Process Validation in Manufacturing of Biopharmaceuticals is a practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. A pivotal text in its field, this new edition provides guidelines and current practices, contains industrial case studies, and is expanded to include in-depth analysis of the new Process Validation (PV) guidance from the US FDA.

Key Features:

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• Offers readers a thorough understanding of the key concepts that form the basis of a good process validation program for biopharmaceuticals.

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• Includes case studies from the various industry leaders that demonstrate application of these concepts.

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• Discusses the use of modern tools such as multivariate analysis for facilitating a process validation exercise.

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• Covers process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration, and practical methods to test raw materials and in-process samples.

Providing a thorough understanding of the key concepts that form the basis of a good process validation program, this book will help readers ensure that PV is carried out and exceeds expectations. Fully illustrated, this is a much-needed practical guide for biopharmaceutical manufacturers.

Table of contents

• Cover
• Half Title
• Series
• Title
• Copyright
• Contents
• Author Biographies
• List of Contributors
• 1 The Evolution of Modern Process Validation: Commentary on the U.S. Food and Drug Administration’s 2011 Guidance for Industry, Process Validation Principles and Practices
• 2 Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes
• 3 Process Characterization
• 4 Scale-Down Models for Microbial and Mammalian Cell Culture Processes: Approaches and Applications
• 5 Scale-Down Models for Purification Processes: Approaches and Applications
• 6 Principles of Quality Risk Management for Validation
• 7 Lifespan Studies for Chromatography and Filtration Media
• 8 Analytical Test Methods for Well-Characterized Biological and Biotechnological Products
• 9 Adventitious Agents: Concerns and Testing for Biopharmaceuticals
• 10 Biotech Facility Design for Validation
• 11 Process Validation at Contract Manufacturing Organizations: Approaches, Incentives, Benefits, and Risks
• 12 Validation of a Filtration Step
• 13 Validation of Continuous Bioprocesses
• 14 Role of Multivariate Analysis in Process Validation
• 15 Process Development for Plasmid DNA Production
• Index