Ma, G; Zhou, Y; (2016) Ultra Scale-down Tools to Accelerate Process Development. Presented at: BioTalk 2016: Biological Manufacturing Excellence, Berlin, Germany.

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Abstract

Ultra-scale down tools has played a key role to accelerate process development and reduce process development cost. Using ultra-scale down technology, a wider range of design space becomes affordable to be explored and the time and material usage can be reduced in process development phase. This presentation will show an ultra-scale down device that enjoys the simplicity of dead-end mode of filtration operation to mimic flux and transmembrane pressure relationship in cross-flow filtration process. However the ultra-scale down device only mimics part of the microfiltration process operation due to different configuration. By understanding the system resistance in the microfiltration process, we have used water test to find out the resistance from the large scale unit configuration. An integrated approach of combining the ultra-scale down data and water test data has been taken to develop a protocol of predicting flux and transmembrane relationship in the large scale microfiltration process. How to use the protocol will be demonstrated by a case study where the antibody fragment (Fab) is recovered from an E coli homogenate after the cell lysis step. The impact of this work is the reduction of large scale experimentation during microfiltration process optimisation.

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