Process Validation in Manufacturing of Biopharmaceuticals

Anurag Singh Rathore, Hal Baseman, Scott Rudge, Anurag Singh Rathore, Hal Baseman, Scott Rudge

• Éditeur: CRC Press
• Année: 2023
• ISBN:
  9781003805472
• Édition: 4
• Sujet: Médecine
• Sous-sujet: Pharmacologie

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:

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• Offers readers a thorough understanding of the key concepts that form the basis of a good process validation program for biopharmaceuticals.

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• Includes case studies from the various industry leaders that demonstrate application of these concepts.

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• Discusses the use of modern tools such as multivariate analysis for facilitating a process validation exercise.

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• 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.