ABSTRACT

Written by experienced authorities in process validation, Process Validation in Manufacturing of Biopharmaceuticals explores current trends in the field and strategies for the selection of the most appropriate quality control scheme. It offers practical guidelines, recommendations, and an abundance of industrial case studies that demonstrate variou

chapter 1|12 pages

1

chapter 2|18 pages

2

chapter 3|38 pages

Process Characterization

chapter 7|72 pages

Validation of a Filtration Step

chapter 10|56 pages

Validation of Computerized Systems

chapter 11|18 pages

11

chapter 12|54 pages

12

chapter 14|20 pages

Viral Clearance Validation: A Case Study