Viser: Process Validation in Manufacturing of Biopharmaceuticals
Process Validation in Manufacturing of Biopharmaceuticals Vital Source e-bog
Anurag Singh Rathore
(2023)
Process Validation in Manufacturing of Biopharmaceuticals
Anurag Singh Rathore, Harold Baseman og Scott Rudge
(2023)
Sprog: Engelsk
om ca. 10 hverdage
Detaljer om varen
- 4. Udgave
- Vital Source searchable e-book (Reflowable pages)
- Udgiver: Taylor & Francis (December 2023)
- ISBN: 9781003805472
Bookshelf online: 5 år fra købsdato.
Bookshelf appen: ubegrænset dage fra købsdato.
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Detaljer om varen
- 4. Udgave
- Hardback: 552 sider
- Udgiver: Taylor & Francis Group (December 2023)
- Forfattere: Anurag Singh Rathore, Harold Baseman og Scott Rudge
- ISBN: 9780367697624
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.