ACHIEVING SEAMLESS SCALE-UP AND TECHNOLOGY TRANSFER - A CASE STUDY IN SINGLE-USE BIOREACTORS

Presented by Ying Wang, Ph.D, Senior Scientist I, Manufacturing Sciences, AbbVie Bioresearch Center.
A systematic scale-up strategy is critical in enabling a rapid and robust technical transfer. For a program involving a CHO cell culture process, a combination of mass-transfer kLa studies, computational simulation and scale-down model experiments were used within this newly developed workflow. Utilizing this approach, scale-up was successfully accelerated less 4 months with titer improvement and comparable product quality. The main lessons learned from this case study will be presented.