Process Validation in Manufacturing of Biopharmaceuticals (Biotechnology and Bioprocessing)

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Synopsis
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.
Copyright:
2022

Book Details

Book Quality:
Publisher Quality
ISBN-13:
9781003805472
Related ISBNs:
9780367697631, 9781003143130, 9780367697624
Publisher:
CRC Press
Date of Addition:
Copyrighted By:
selection and editorial matter, Anurag S. Rathore, Hal Baseman, Scott Rudge
Adult content:
No
Language:
English
Has Image Descriptions:
No
Categories:
Nonfiction, Science, Medicine
Submitted By:
Bookshare Staff
Usage Restrictions:
This is a copyrighted book.
Edited by:
Anurag Singh Rathore
Edited by:
Hal Baseman
Edited by:
Scott Rudge

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