Process Validation in Manufacturing of Biopharmaceuticals PDF
Edited by Anurag Singh Rathore, Hal Baseman, Scott Rudge
Part of the Biotechnology and Bioprocessing series
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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.
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Download Now
- Format:PDF
- Pages:410 pages
- Publisher:CRC Press
- Publication Date:18/12/2023
- Category:
- ISBN:9781003805465
Information
-
Download Now
- Format:PDF
- Pages:410 pages
- Publisher:CRC Press
- Publication Date:18/12/2023
- Category:
- ISBN:9781003805465