ABSTRACT
Bayer Biotechnology divides biopharmaceutical process development and validation into six distinct stages: 1) process research and early process development, 2) process development, 3) clinical manufacture, 4) process transfer, 5) process qualification, and 6) process maintenance. In this chapter, we summarize the work characterizing each of these stages and describe the validation strategy and procedures that accompany process development. Each phase of development and validation contributes to the improved control of the final commercial process. This systematic life-cycle approach provides an ordered system for commercial process change following licensure (Fig. 1).
