バイオ薬剤の製造におけるプロセス認証（第４版） Process Validation in Manufacturing of Biopharmaceuticals（4）

著者名：Singh Rathore, Anurag (EDT)/Baseman, Hal (EDT)/Rudge, Scott (EDT)

CRC Press（2023/12/18発売）

• 言語：ENG
• ISBN：9780367697624
• eISBN：9781003805472

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.

Table of Contents

1. The Evolution of Modern Process Validation: Commentary on the U.S. Food and Drug Administration’s 2011 Guidance for Industry, Process Validation Principles and Practices

Hal Baseman

2. Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes

Robert J. Seely and John Haury

3. Process Characterization

James E. Seely

4. Scale-Down Models for Microbial and Mammalian Cell Culture Processes: Approaches and Applications

Ravali Raju et al.

5. Scale-Down Models for Purification Processes: Approaches and Application

Arch Creasy et al.

6. Principles of Quality Risk Management for Validation

Tiffany Baker and Patrick Mains

7. Lifespan Studies for Chromatography and Filtration Media

Anurag S. Rathore and Gail Sofer

8. Analytical Test Methods for Well-Characterized Biological and Biotechnological Products

Nadine Ritter and John McEntire

9. Adventitious Agents: Concerns and Testing for Biopharmaceuticals

Raymond W. Nims et al.

10. Biotech Facility Design for Validation

Phil DeSantis

11. Process Validation at Contract Manufacturing Organizations: Approaches, Incentives, Benefits, and Risks

Maria Wik and Scott Rudge

12. Validation of a Filtration Step

Jennifer Campbell et al.

13. Validation of Continuous Bioprocesses

Marc Bisschops and Mark Schofield

14. Role of Multivariate Analysis in Process Validation

Anurag S. Rathore and Vishwanath Hebbi

15. Process Development for Plasmid DNA Production

Frank Agbogdo et al.