Department of Chemical Engineering, McMaster University, Hamilton, Canada.
J Sep Sci. 2022 Jun;45(12):2024-2033. doi: 10.1002/jssc.202200183. Epub 2022 Apr 11.
This paper discusses ultrahigh-speed, ultrahigh-resolution preparative protein separation using an in-house designed membrane chromatography device. The performance of the membrane chromatography device was systematically compared with an equivalent resin-packed preparative column. Experiments carried out using model proteins showed that membrane chromatography gave more than four times greater resolution than the preparative column, while at the same time being more than 19 times faster. Membrane chromatography was therefore a better option, not only in terms of higher productivity but also in terms of higher product purity. Membrane chromatography was also superior in terms of resolving and presenting tracer impurity peaks in the chromatogram. Experiments carried out using monoclonal antibody samples showed that membrane chromatography was suitable for ultrahigh speed, and ultrahigh resolution fractionation of charge variants. This paper highlights and explains the need for proper device design for enabling the use of membrane chromatography for the efficient purification of protein biopharmaceuticals.
本文讨论了使用内部设计的膜色谱设备进行超高速度、超高分辨率的蛋白质制备分离。系统比较了膜色谱设备与等效的树脂填充制备柱的性能。使用模型蛋白质进行的实验表明，膜色谱的分辨率比制备柱高出四倍以上，同时速度快 19 倍以上。因此，膜色谱不仅在更高的生产效率方面，而且在更高的产品纯度方面都是更好的选择。膜色谱在解决和呈现色谱图中的示踪杂质峰方面也具有优势。使用单克隆抗体样品进行的实验表明，膜色谱适用于超高速度和超高分辨率的电荷变异体分离。本文强调并解释了需要进行适当的设备设计，以便在蛋白质生物制药的高效纯化中使用膜色谱。
