Process Validation in Manufacturing of Biopharmaceuticals

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(R) Purification Process: A Case Study, Lynn Conley, John McPherson, and Jorg Thommes 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