Process Validation in Manufacturing of Biopharmaceuticals (2024) Anurag S. Rathore

Description

A practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. This new edition provides guidelines, current practices, industrial case studies, and an in-depth analysis of the new process validation (PV) guidance from the US FDA, covering key concepts, multivariate analysis, and process characterization techniques.