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Process Validation in Manufacturing of Biopharmaceuticals
335,95 €
+ 671 points
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.
Spécifications
Parties prenantes
- Editeur:
Contenu
- Nombre de pages :
- 392
- Langue:
- Anglais
- Collection :
Caractéristiques
- EAN:
- 9780367697624
- Date de parution :
- 18-12-23
- Format:
- Livre relié
- Format numérique:
- Genaaid
- Dimensions :
- 178 mm x 254 mm
- Poids :
- 929 g
