Wow! eBook
Process Validation in Manufacturing of Biopharmaceuticals (Biotechnology and Bioprocessing)
by: Anurag Singh Rathore (Editor), Hal Baseman (Editor), Scott Rudge (Editor)
Edition: 4th
Publication Date: 2023-12-18
Language: English
Print Length: 412 pages
ISBN-10: 0367697629
ISBN-13: 9780367697624
Book Description
The fourth edition of Process Validation in Manufacturing of Biopharmaceuticals is a practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. A pivotal text in its field, this new edition provides guidelines and current practices, contains industrial case studies, and is expanded to include in-depth analysis of the new Process Validation (PV) guidance from the US FDA.Key Features:Offers readers a thorough understanding of the key concepts that form the basis of a good process validation program for biopharmaceuticals.Includes case studies from the various industry leaders that demonstrate application of these concepts.Discusses the use of modern tools such as multivariate analysis for facilitating a process validation exercise.Covers process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration, and practical methods to test raw materials and in-process samples.Providing a thorough understanding of the key concepts that form the basis of a good process validation program, this book will help readers ensure that PV is carried out and exceeds expectations. Fully illustrated, this is a much-needed practical guide for biopharmaceutical manufacturers.
Editorial Reviews
The fourth edition of Process Validation in Manufacturing of Biopharmaceuticals is a practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. A pivotal text in its field, this new edition provides guidelines and current practices, contains industrial case studies, and is expanded to include in-depth analysis of the new Process Validation (PV) guidance from the US FDA.Key Features:Offers readers a thorough understanding of the key concepts that form the basis of a good process validation program for biopharmaceuticals.Includes case studies from the various industry leaders that demonstrate application of these concepts.Discusses the use of modern tools such as multivariate analysis for facilitating a process validation exercise.Covers process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration, and practical methods to test raw materials and in-process samples.Providing a thorough understanding of the key concepts that form the basis of a good process validation program, this book will help readers ensure that PV is carried out and exceeds expectations. Fully illustrated, this is a much-needed practical guide for biopharmaceutical manufacturers.
