Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes.
Case studies include
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Process validation for membrane chromatography
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Leveraging multivariate analysis tools to qualify scale-down models
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A matrix approach for process validation of a multivalent bacterial vaccine
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Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells
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Viral clearance validation studies for a product produced in a human cell line
A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.
Preface
Chapter 1 : Guidelines to Process Validation
Chapter 2 : Commentary on the US Food and Drug Administration’s 2011 "Guidance for Industry, Process Validation General Principles and Practices"
Chapter 3 : Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes
Chapter 4 : Process Characterization
Chapter 5 : Scale-Down Models for Purification Processes : Approaches and Applications
Chapter 6 : Adventitious Agents : Concerns and Testing for Biopharmaceuticals
Chapter 7 : Lifespan Studies for Chromatography and Filtration Media
Chapter 8 : Validation of a Filtration Step
Chapter 9 : Analytical Test Methods for Well-Characterized Biological and Biotechnological Products
Chapter 10 : Facility Design Issues : A Regulatory Perspective
Chapter 11 : Validation of Computerized Systems
Chapter 12 : Process Validation with a CMO
Chapter 13 : Risk Management & Validation
Chapter 14 : Process Validation in Membrane Chromatography
Chapter 15 : Leveraging Multivariate Analysis Tools to Qualify Scaled-Down Models
Chapter 16 : Process Validation of a Multivalent Bacterial Vaccine : A Novel Matrix Approach
Chapter 17 : Validation of the Zevalin Purification Process : A Case Study
Chapter 18 : Viral Clearance Validation : A Case Study, Michael Rubino
Index
