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The development of a bioprocess from the bench scale to industrial scale involves a highly demanding and time consuming piloting phase. This often occurs at a critical time in process development and there is considerable pressure on the responsible scientist/engineer to arrive at an acceptable specification with minimum number of pilot plant trials. Real-time decision making can be made possible by the availability of rapid information and the use of on-line predictive model design to give the development engineer new process information in an optimum graphical form. A potential operation for the downstream processing of intracellular proteins is selective flocculation. By selectively removing cell debris and nucleic acids in a single stage, considerable saving can potentially be made on the overall cost of protein purification. When developing the process from bench to pilot scale, it is important to identify the desired cut fraction for contaminant removal and product recovery. The study demonstrates that with real-time measurements of the product and contaminants, as well as the use of advanced statistical analysis tools, it is possible to identify, in real-time, appropriate piloting conditions necessary to develop process understanding. |
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