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Process Validation in Manufacturing of Biopharmaceuticals. 4th edition
・ISBN 978-0-367-69762-4 hard GB£ 210.00
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| 著者・編者 | Singh Rathore, Anurag / Baseman, Hal / Rudge, Scott (eds.), |
|---|---|
| シリーズ | (Biotechnology and Bioprocessing) |
| 出版社 | (CRC Press, UK) |
| 出版年月 | 2023 |
| ページ数 | 392 pp. |
| 言語 | ENG |
| ニュース番号 | ＜A00-82847＞ |
解説
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.