目次

Guidelines to Process Validation, Gail SoferCommentary on the US Food and Drug Administration’s 2011 "Guidance for Industry, Process Validation General Principles and Practices", Hal BasemanApplications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes, Robert J. Seely and John HauryProcess Characterization, James E. SeelyScale-Down Models for Purification Processes: Approaches and Applications, Ranga Godavarti, Jon Petrone, Jeff Robinson, Richard Wright,Brian D. Kelley, and Glen R. BoltonAdventitious Agents: Concerns and Testing for Biopharmaceuticals, Raymond W. Nims, Esther Presente, Gail Sofer, Carolyn Phillips, and Audrey ChangLifespan Studies for Chromatography and Filtration Media, Anurag Rathore and Carol SoferValidation of a Filtration Step, Jennifer CampbellAnalytical 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 KavanaughValidation of Computerized Systems, Monica J. CahillyProcess Validation with a CMO, Susan Dana Jones, Sheila G. Magil, and Gail SoferRisk Management & Validation, James AgallocoProcess Validation in Membrane Chromatography, Suma Ray and Miyako HiraiLeveraging Multivariate Analysis Tools to Qualify Scaled-Down Models, John Pieracci and Helena Yusuf-MakagiansarProcess 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. LeeValidation of the Zevalin® Purification Process: A Case Study, Lynn Conley, John McPherson, and Jörg ThömmesViral Clearance Validation: A Case Study, Michael Rubino, Mark Bailey, Jeffrey C. Baker, Jeri Ann Boose, Lorraine Metzka, Valerie Moore, Michelle Quertinmont, and William Wiler