Process Validation in Manufacturing of Biopharmaceuticals

Written by experienced authorities in process validation, this book explores strategies for selecting the most appropriate quality control processes. It offers practical guidelines, recommendations, and an abundance of industrial case studies that demonstrate various techniques and approaches in the validation of biopharmaceutical processes. This third edition of the text addresses the numerous changes made in the pharmaceutical industry as well as the many modifications that have been made to regulations. In addition, the authors also cover advances in biotechnology.