This presentation will describe the approach that was employed to verify the suitability of a scale down model for process characterization studies of a cell culture process. The cell culture process was developed and characterized at the 3-L bioreactor scale. The process was successfully scaled up to 15000-L scale using experience at intermediate scales and mass transfer characterization data of the large scale bioreactor. In parallel, the scale down model was examined by running satellite cultures of the15000-L bioreactors. The presentation will detail the statistical approach that was used to assess the similarity/differences between the performances at two scales. The presentation will particularly focus on the scientific approach that was used to qualify the small scale bioreactor as a predictive model of the large scale performance despite the minor differences observed between two scales. The approach utilized the analyses based on mechanistic models as well as empirical studies.

Approach to scale down model verification of a cell culture process

247th National Meeting (2014)

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.