Process Validation in Manufacturing of Biopharmaceuticals explores current trends in the field and strategies for the selection of the most appropriate quality control scheme.

Features:

• Process characterization and techniques for scaling-down unit operations that are commonly used in biopharmaceutical manufacturing
• Guidance on determination of lifespan of chromatography and filtration media
• A chapter on facility design and inspection by a former FDA official-including sections on license application, utilities, cleaning, and environmental monitoring, as well as issues specific to multi-product facilities
• Discussion of computerized system compliance
• Examples of contamination events, as well as tables describing adventitious agents and recommended testing programs
• Practical methods to test raw materials and in-process samples during various manufacturing stages
• Case studies highlighting validation approaches successfully taken in the industry

Contents

• Guidelines to Process Validation
• 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
• Life Span Studies for Chromatography and Filtration Media
• Validation of a Flitration Strap
• Analytical Test Methods for Well-Characterized Biological and Biotechnological Products
• Facility Design Issues-A Regulatory Perspective
• Validation of Computerized Systems
• Process Optimization and Characterization Studies for Purification of an E. coli-Expressed Protein Product
• Validation of the ZEVALINÒ Purification Process - A Case Study
• Process Validation of a Multivalent Bacterial Vaccine: A Novel Matrix Approach

Index

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