(538e) Scale-Down Modeling of Continuous Centrifugation for Mammalian Cell Culture Harvest

Disc Stack centrifuge has been widely used in the mammalian cell culture for continuous harvest process.  It is often used as the primary clarification step to remove cell debris, cells and other impurities.   Pilot scale disc stack centrifuge has been used to model the manufacturing scale; however its requirement for utilizing a significant amount of resources and materials makes the bench-top scale more appealing.  Whisperfuge, a bench-top centrifuge, as well as a combination of shear device and batch centrifuge were studied to model the production and the pilot scale continuous centrifuges.  Responses of centrate turbidity, Lactate dehydrogenase (LDH) and particle size indicated good reproduction of process scalability.  The capability of generating a great amount of experimental data at a small scale efficiently renders greater process characterization and optimization for mammalian cell culture harvest operations. Furthermore, a small scale bench-top model could deliver material for filter sizing studies and could address potential scale up issues earlier during the process development.