Poster: Linear Scalability of Virus Production in Integrity® iCELLis® Single-Use, Fixed-Bed Bioreactors From Bench Scale to Industrial Scale
Presenter: Stéphanie Dubois, ATMI LifeSciences
About: Viral vaccines are usually produced by anchorage-dependent cells in static multitray systems, roller bottles or bioreactors with microbeads. However, these technologies do not enable process intensification as they involve many manual operations. To enable process intensification, ATMI developed iCELLis®, a scalable range of disposable pre-packed fixed-bed bioreactors that operate in perfusion mode. The fixed-bed accommodates up to 500m² of growth surface area in only 25 liters reactor volume. It can be inoculated at a very low cell density which simplifies seed train. Here we present the scale-up of MDBK, Vero and HEK293 processes from iCELLis benchtop bioreactor to production units. Scaling-up with iCELLis systems is quick and similar to that of chromatography columns. As the bioreactor scale increases, the fixed-bed height remains constant while the diameter increases. Small scale processes were transferred to large scale iCELLis by keeping same culture parameters (pH, DO & Temp), identical ratios for cells/surface and media/cells, compaction of carriers, the linear speed through the fixed-bed and the perfusion rate. The study demonstrated that iCELLis bioreactors simplify viral production processes and that linear scale-up in iCELLis is easily developed from 0.53m² to 500m² in less than one year.
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