Model-based methodology for design and analysis of preparative chromatography is becoming an interesting tool in pharmaceutical industry because it gives both a deep insight into the process behavior and an efficient process design tool for quantitative predictions. An example of model-based design of an integrated process composed of a reaction step and a purification step is presented.The first step in the process is a reactor for PEGylation of a target protein. The second step is a chromatographic purification of the target mono-PEGylated protein from unreacted and di-PEGylated impurities. The difference between optimizing the two steps separately and optimizing them simultaneously is studied.It was found that by optimizing the two steps simultaneously up to 100% increase in productivity could be obtained without reduction of yield. The effect of recycling of unreacted protein was also studied and the yield could be increased by 30%.

Model-based design of integrated reactor-chromatography process

247th National Meeting (2014)

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