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: Offers readers a thorough understanding of the key concepts that form the basis of a good process validation program for biopharmaceuticals. Includes case studies from the various industry leaders that demonstrate application of these concepts. Discusses the use of modern tools such as multivariate analysis for facilitating a process validation exercise. 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:
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 Hal Baseman Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes Robert J. Seely and John Haury Process Characterization James E. Seely Scale-Down Models for Microbial and Mammalian Cell Culture Processes: Approaches and Applications Ravali Raju et al. Scale-Down Models for Purification Processes: Approaches and Application Arch Creasy et al. Principles of Quality Risk Management for Validation Tiffany Baker and Patrick Mains Lifespan Studies for Chromatography and Filtration Media Anurag S. Rathore and Gail Sofer Analytical Test Methods for Well-Characterized Biological and Biotechnological Products Nadine Ritter and John McEntire Adventitious Agents: Concerns and Testing for Biopharmaceuticals Raymond W. Nims et al. Biotech Facility Design for Validation Phil DeSantis Process Validation at Contract Manufacturing Organizations: Approaches, Incentives, Benefits, and Risks Maria Wik and Scott Rudge Validation of a Filtration Step Jennifer Campbell et al. Validation of Continuous Bioprocesses Marc Bisschops and Mark Schofield Role of Multivariate Analysis in Process Validation Anurag S. Rathore and Vishwanath Hebbi Process Development for Plasmid DNA Production Frank Agbogdo et al.