Application of quality by design principles to the development and technology transfer of a major process improvement for the manufacture of a recombinant protein.

Abstract

This study describes the application of quality by design (QbD) principles to the development and implementation of a major manufacturing process improvement for a commercially distributed therapeutic protein produced in Chinese hamster ovary cell culture. The intent of this article is to focus on QbD concepts, and provide guidance and understanding on how… (More)
DOI: 10.1002/btpr.672

Topics

11 Figures and Tables