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
- Process validation for membrane chromatography
- Leveraging multivariate analysis tools to qualify scale-down models
- A matrix approach for process validation of a multivalent bacterial vaccine
- Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells
- 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.
Table of Contents
Guidelines to Process Validation, Gail Sofer
Commentary on the US Food and Drug Administration’s 2011 "Guidance for Industry, Process Validation General 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 Purification Processes: Approaches and Applications, Ranga Godavarti, Jon Petrone, Jeff Robinson, Richard Wright,
Brian D. Kelley, and Glen R. Bolton
Adventitious Agents: Concerns and Testing for Biopharmaceuticals, Raymond W. Nims, Esther Presente, Gail Sofer, Carolyn Phillips, and Audrey Chang
Lifespan Studies for Chromatography and Filtration Media, Anurag Rathore and Carol Sofer
Validation of a Filtration Step, Jennifer Campbell
Analytical Test Methods for Well-Characterized Biological and Biotechnological Products, Nadine Ritter, Ph.D. and John McEntire, Ph.D.
Facility Design Issues: A Regulatory Perspective, Susan Vargo and Nancy Kavanaugh
Validation of Computerized Systems, Monica J. Cahilly
Process Validation with a CMO, Susan Dana Jones, Sheila G. Magil, and Gail Sofer
Risk Management & Validation, James Agalloco
Process Validation in Membrane Chromatography, Suma Ray and Miyako Hirai
Leveraging Multivariate Analysis Tools to Qualify Scaled-Down Models, John Pieracci and Helena Yusuf-Makagiansar
Process Validation of a Multivalent Bacterial Vaccine: A Novel Matrix Approach, Narahari S. Pujar, Marshall G. Gayton, Wayne K. Herber, Chitrananda Abeygunawardana, Michael L. Dekleva, P. K. Yegneswaran, and Ann L. Lee
Validation of the Zevalin® Purification Process: A Case Study, Lynn Conley, John McPherson, and Jörg Thömmes
Viral Clearance Validation: A Case Study, Michael Rubino, Mark Bailey, Jeffrey C. Baker, Jeri Ann Boose, Lorraine Metzka, Valerie Moore, Michelle Quertinmont, and William Wiler
ANURAG S. RATHORE is a consultant of Biotech CMC Issues. He is also a faculty at the Department of Chemical Engineering, Indian Institute of Technology, Delhi, India. His previous roles included management positions at Amgen Inc., Thousand Oaks, California and Pharmacia Corp., St. Louis, Missouri. His areas of interest include process development, scale-up, technology transfer, process validation, process analytical technology and quality by design. He has authored more than 180 publications and presentations in these areas. He is presently serving as the Editor-in-Chief of Preparative Biochemistry and Biotechnology and serves on the Editorial Advisory Boards for Biotechnology Progress, BioPharm International, Pharmaceutical Technology Europe and Separation and Purification Reviews. Dr. Rathore has edited books titled Quality by Design for Biopharmaceuticals: Perspectives and Case Studies (2009), Elements of Biopharmaceutical Production (2007), Process Validation (2005), Electrokinetic Phenomena (2004) and Scale-up and Optimization in Preparative Chromatography (2003). He has a Ph.D. in Chemical Engineering from Yale University.
Gail Sofer: After serving as the director of Regulatory Services at BioReliance for 6 years, Dr. Sofer has recently joined GE Healthcare (formerly Amersham Biosciences) as the director of Regulatory Compliance in a new consulting team. Her publications include numerous articles and book chapters on downstream processing, virus inactivation, and validation. She has also coedited and authored several books. She serves on the Science Advisory Board of PDA, the Editorial Advisory Boards of BioPharm, BioQuality, and BioProcess International, and the Scale-Up Advisory Board of Genetic Engineering News. She chairs a PDA task force on virus filters and is cochair of the ASTM subcommittee on Adventitious Agents for Tissue Engineered Medical Products. She holds an M.S. degree in biochemistry from the University of Miami.