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
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.
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