Appropriate scale-up/down is key for further larger production. Important is to focus to the right parameters that can help us to set the design for all experiments at lab scale.
The common approach within the up-stream processing (USP) part in biologics is to increase the scale 10 times. It means from e.g. 25L lab scale to max. 250L pilot scale and later on from pilot scale to max 2500L production scale. Key parameters are vessel geometry, agitation, aeration, back-pressure and feeding profiles (in case of fed-batch fermentation). Next diagram shows typical construction of a common fermenter with key parameters:
Geometric similarity of fermenter geometry is a pre-requisite for applying established scale-up relationship. It´s expressed as follows: DT2/DT1 = (VT2/VT1)1/3, where DTi is fermenter diameter and VTi total fermenter volume. Geometric similarity also assumes reasonably constant impeller geometry such as impeller diameter (DI) and number of impellers (N).
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