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.
- 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.
- 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
- Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes
- Process Characterization
- Scale-Down Models for Microbial and Mammalian Cell Culture Processes: Approaches and Applications
- Scale-Down Models for Purification Processes: Approaches and Application
- Principles of Quality Risk Management for Validation
- Lifespan Studies for Chromatography and Filtration Media
- Analytical Test Methods for Well-Characterized Biological and Biotechnological Products
- Adventitious Agents: Concerns and Testing for Biopharmaceuticals
- Biotech Facility Design for Validation
- Process Validation at Contract Manufacturing Organizations: Approaches, Incentives, Benefits, and Risks
- Validation of a Filtration Step
- Validation of Continuous Bioprocesses
- Role of Multivariate Analysis in Process Validation
- Process Development for Plasmid DNA Production
Robert J. Seely and John Haury
James E. Seely
Ravali Raju et al.
Arch Creasy et al.
Tiffany Baker and Patrick Mains
Anurag S. Rathore and Gail Sofer
Nadine Ritter and John McEntire
Raymond W. Nims et al.
Maria Wik and Scott Rudge
Jennifer Campbell et al.
Marc Bisschops and Mark Schofield
Anurag S. Rathore and Vishwanath Hebbi
Frank Agbogdo et al.