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Full Description
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.
Contents
Guidelines to Process Validation. Commentary on the US Food and Drug Administration's 2011 "Guidance for Industry, Process Validation General Principles and Practices". Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes. Process Characterization. Scale-Down Models for Purification Processes: Approaches and Applications. Adventitious Agents: Concerns and Testing for Biopharmaceuticals. Lifespan Studies for Chromatography and Filtration Media. Validation of a Filtration Step. Analytical Test Methods for Well-Characterized Biological and Biotechnological Products. Facility Design Issues: A Regulatory Perspective. Validation of Computerized Systems. Process Validation with a CMO. Risk Management & Validation. Process Validation in Membrane Chromatography. Leveraging Multivariate Analysis Tools to Qualify Scaled-Down Models. Process Validation of a Multivalent Bacterial Vaccine: A Novel Matrix Approach. Validation of the Zevalin® Purification Process: A Case Study. Viral Clearance Validation: A Case Study.
