(430f) Qualification of a Scale Down Cell Culture Model for Process Characterization Studies

Process characterization studies are performed to gain an increased understanding of the robustness of late stage clinical processes. Since these experiments cannot be performed at large scale due to the number of runs and the associated cost, a representative scale down model of the manufacturing process is desirable.

A case study will be presented on the qualification of a scale down model for a late stage clinical product manufactured using a CHO fed-batch process. There were differences in key process attributes, like growth and productivity profiles, between the large scale manufacturing process and the bench scale model used during initial development. The scale down model development involved assessment of scale-related engineering parameters (such as mass transfer coefficient, power per unit volume, and gas sparge rate) on key process attributes. The application of the scale down model for process characterization studies was explored. The rationale behind the experimental design will be discussed and the results will be presented.