Process validation in manufacturing of biopharmaceuticals : guidelines, current practices, & industrial case studies

Written by experienced authorities in process validation, this reference explores current trends in the field, as well as strategies for the selection of the most appropriate quality control scheme. Delivering practical guidelines, recommendations, and an abundance of industrial case-studies that showcase various techniques and approaches in the validation of biopharmaceutical processes, this guide contains : process characterization and techniques for scaling-down unit operations that are commonly used in biopharmaceutical manufacturing, 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, specific examples of failure modes and effect analysis (FMEA) to help readers establish this method in their particular organization.

Guidelines to Process Validation. Process Characterization. Lifespan Studies for Chromatography and Filtration Media. Facility Design Issues-A Regulatory Perspective. Validation of Computerized Systems. Case Study: Process Optimization and Characterization Studies for Purification of an E. coli Expressed Protein Product. Case Study: Xigris Viral Clearance Validation Studies.