Angarita Monica, Müller-Späth Thomas, Baur Daniel, Lievrouw Roel, Lissens Geert, Morbidelli Massimo
Institute for Chemical and Bioengineering, Department of Chemistry and Applied Biosciences, ETH Zürich, Switzerland(1).
Institute for Chemical and Bioengineering, Department of Chemistry and Applied Biosciences, ETH Zürich, Switzerland(1); ChromaCon AG, Zürich, Switzerland(2).
J Chromatogr A. 2015 Apr 10;1389:85-95. doi: 10.1016/j.chroma.2015.02.046. Epub 2015 Feb 21.
A twin-column counter-current chromatography processes, CaptureSMB, was used for the protein A affinity capture of a monoclonal antibody (mAb). By means of sequential loading, the process improves the utilization of the stationary phase by achieving loadings much closer to the static binding capacity of the resin in comparison to batch chromatography. Using a mAb capture case study with protein A affinity chromatography, the performance and product quality obtained from CaptureSMB and batch processes were compared. The effect of the flow rate, column length and titer concentration on the process performance and product quality were evaluated. CaptureSMB showed superior performance compared to batch chromatography with respect to productivity, capacity utilization, product concentration and buffer consumption. A simplified economic evaluation showed that CaptureSMB could decrease resin costs of 10-30% depending on the manufacturing scenario.
采用双柱逆流色谱工艺(CaptureSMB)对单克隆抗体(mAb)进行蛋白A亲和捕获。通过连续上样,与分批色谱相比,该工艺通过实现更接近树脂静态结合容量的上样量,提高了固定相的利用率。通过蛋白A亲和色谱的单克隆抗体捕获案例研究,比较了CaptureSMB和分批工艺的性能及产品质量。评估了流速、柱长和效价浓度对工艺性能和产品质量的影响。在生产率、容量利用率、产品浓度和缓冲液消耗方面,CaptureSMB表现出优于分批色谱的性能。一项简化的经济评估表明,根据生产情况,CaptureSMB可降低10%-30%的树脂成本。