Process Validation in Manufacturing of Biopharmaceuticals (Hardcover, 4 ed)

1. Update on the US 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

Anurag S. Rathore, Robert J. Seely, John Haury

3. Process Characterization

Anurag S. Rathore, Jim Seely

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

Ravali Raju, Jin Guo, Jennifer Pulkowski, Tatenda Shopera, Xiaolu Zheng, Nichole Wood

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

Arch Creasy, Brenda Carrillo Conde, Steve Kolodziej, Frank Kotch, Russ Shpritzer, Ranga Godavarti

6. Quality Risk Management and Validation

Patrick Mains, Tiffany Baker

7. Lifespan Studies for Chromatography and Filtration Media

Anurag S. Rathore, Gail Sofer

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

Nadine Ritter, John McEntire

9. Adventitious Agents: Concerns and Testing for Biopharmaceuticals

Ray Nims, Esther Presente, Gail Sofer. Carolyn Phillips, Audrey Chang

10. Facility Design Issues-A Regulatory Perspective

Phil DeSantis

11. Process Validation with a CMO

Scott Rudge

12. Validation of a Filtration

Nargisse El Haijami, Pascale Richert, Guillaume Lesage, Renato Lorenzi

13. Process Validation in the Continuous Processing Paradigm

Marc Bisschops, Mike Collins

14. Case Study: Application of Multivariate Analysis in Process Validation

Anurag S. Rathore

15. Case Study: Development of a Downstream Isolation Process for GMP pDNA

Frank Agbogdo, Lin Hong, April Stanley, Dawn Woford, Jesse McCool, David Schmidt