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  3. Process Validation in Manufacturing of Biopharmaceuticals, 4th Edition

Process Validation in Manufacturing of Biopharmaceuticals, 4th Edition

Posted By: yoyoloit
Date: 27 Dec 2024 10:27:49
Process Validation in Manufacturing of Biopharmaceuticals, 4th Edition

Process Validation in Manufacturing of Biopharmaceuticals; Fourth Edition
by Anurag Singh Rathore
English | 2024 | ISBN: 0367697629 | 413 pages | True PDF | 56.01 MB


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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