(249b) Establishment of a Disposable Platform Process and Comparability Study to Stainless Steel Bioreactors

Flexible platform processes and operation facilities are needed to manage a wide range of material demand and variability in unit operations. Boehringer Ingelheim has successfully established our global disposable platform process, which allows us to efficiently meet the demands of global trials and markets. A good understanding of the fundamental engineering aspects and comparability between the disposable and stainless steel bioreactors is important for process transfer between different bioreactor systems as well as process scale up and down.

This study investigated engineering parameters of disposable bioreactors such as volumetric mass-transfer coefficient, carbon dioxide removal and mixing time, and compared these parameters to stainless steel bioreactors at different scales. This study was performed at different agitation speeds and process transfer between systems was based on power input per volume and volumetric gas flow rates. Finally the comparability was evaluated with a mammalian cell cultivation platform process carried out in different systems.