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首页> 外文期刊>Biotechnology Progress >High-Throughput Process Development: Determination of Dynamic Binding Capacity Using Microliter Filter Plates Filled with Chromatography Resin
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High-Throughput Process Development: Determination of Dynamic Binding Capacity Using Microliter Filter Plates Filled with Chromatography Resin

机译：高通量工艺开发：使用填充有色谱树脂的微升滤板测定动态结合能力

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摘要

Steadily increasing demand for more efficient and more affordable biomolecule-based therapies put a significant burden on biopharma companies to reduce the cost of R&D activities associated with introduction of a new drug to the market. Reducing the time required to develop a purification process would be one option to address the high cost issue. The reduction in time can be accomplished if more efficient methods/tools are available for process development work, including high-throughput techniques. This paper addresses the transitions from traditional column-based process development to a modern high-throughput approach utilizing microtiter filter plates filled with a well-defined volume of chromatography resin. The approach is based on implementing the well-known batch uptake principle into microtiter plate geometry. Two variants of the proposed approach, allowing for either qualitative or quantitative estimation of dynamic binding capacity as a function of residence time, are described. Examples of quantitative estimation of dynamic binding capacities of human polyclonal IgG on MabSelect SuRe and of qualitative estimation of dynamic binding capacity of amyloglucosidase on a prototype of Capto DEAE weak ion exchanger are given. The proposed high-throughput method for determination of dynamic binding capacity significantly reduces time and sample consumption as compared to a traditional method utilizing packed chromatography columns without sacrificing the accuracy of data obtained.
机译：对更有效，更负担得起的基于生物分子的疗法的需求不断增长，给生物制药公司带来了沉重的负担，以降低与将新药投放市场有关的研发活动的成本。减少开发纯化过程所需的时间将是解决高成本问题的一种选择。如果更有效的方法/工具可用于过程开发工作，包括高通量技术，则可以减少时间。本文探讨了从传统的基于色谱柱的工艺开发到现代的高通量方法的转变，该方法采用了填充有确定体积的色谱树脂的微量滴定板。该方法基于将众所周知的批量摄取原理实施到微量滴定板几何形状中。描述了所提出方法的两个变体，其允许对动态结合能力作为停留时间的函数进行定性或定量估计。给出了定量估计人多克隆IgG在MabSelect SuRe上的动态结合能力以及定性估计Capto DEAE弱离子交换剂原型上的淀粉葡糖苷酶动态结合能力的示例。与使用填充色谱柱的传统方法相比，所提出的用于测定动态结合能力的高通量方法显着减少了时间和样品消耗，同时又不牺牲获得数据的准确性。

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