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Model-based design and integration of a two-step biopharmaceutical production process

机译：基于模型的设计和两步生物制药生产过程的集成

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This paper presents the design of a two-step process in which the first step is PEGylation of a protein, and the second step is chromatographic purification of the target mono-PEGylated protein from the unreacted and the di-PEGylated impurities. The difference between optimizing each process step separately and optimizing them simultaneously is studied. It was found that by optimizing the steps simultaneously up to a 100 % increase in productivity could be obtained without reduction in yield. Optimizing both steps at the same time makes it possible for the optimization method to take into account that the di-PEGylated protein is much easier to separate than the non-PEGylated protein. The easier separation makes it possible to get a higher yield and productivity at the same time. The effect of recycling was also studied and the yield could be increased by 30 % by recycling the unreacted protein. However, if maximum productivity is required, batch mode is preferable.
机译：本文介绍了两步法的设计，其中第一步是蛋白质的PEG化，第二步是从未反应和二聚乙二醇化的杂质中色谱纯化目标单PEG化的蛋白质。研究了分别优化每个步骤与同时优化它们之间的区别。发现通过同时优化步骤，可以在不降低产量的情况下获得高达100％的生产率提高。同时优化两个步骤可以使优化方法考虑到二聚乙二醇化的蛋白质比非聚乙二醇化的蛋白质更容易分离。更容易的分离使得可以同时获得更高的产量和生产率。还研究了再循环的效果，并且通过再循环未反应的蛋白质可以使产率提高30％。但是，如果需要最大的生产率，则最好使用批处理模式。

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