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首页> 外文期刊>Biotechnology Progress >Caprylic acid-induced impurity precipitation from protein A capture column elution pool to enable a two-chromatography-step process for monoclonal antibody purification
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Caprylic acid-induced impurity precipitation from protein A capture column elution pool to enable a two-chromatography-step process for monoclonal antibody purification

机译：辛酸诱导的蛋白质A捕获柱洗脱池中的杂质沉淀，可实现两步法纯化单克隆抗体的过程

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摘要

This article presents the use of caprylic acid (CA) to precipitate impurities from the protein A capture column elution pool for the purification of monoclonal antibodies (mAbs) with the objective of developing a two chromatography step antibody purification process. A CA-induced impurity precipitation in the protein A column elution pool was evaluated as an alternative method to polishing chromatography techniques for use in the purification of mAbs. Parameters including pH, CA concentrations, mixing time, mAb concentrations, buffer systems, and incubation temperatures were evaluated on their impacts on the impurity removal, high-molecular weight (HMW) formation and precipitation step yield. Both pH and CA concentration, but not mAb concentrations and buffer systems, are key parameters that can affect host-cell proteins (HCPs) clearance, HMW species, and yield. CA precipitation removes HCPs and some HMW species to the acceptable levels under the optimal conditions. The CA precipitation process is robust at 15-25 degrees C. For all five mAbs tested in this study, the optimal CA concentration range is 0.5-1.0%, while the pH range is from 5.0 to 6.0. A purification process using two chromatography steps (protein A capture column and ion exchange polishing column) in combination with CA-based impurity precipitation step can be used as a robust downstream process for mAb molecules with a broad range of isoelectric points. Residual CA can be effectively removed by the subsequent polishing cation exchange chromatography. (C) 2015 American Institute of Chemical Engineers
机译：本文介绍了使用辛酸（CA）从蛋白A捕获柱洗脱池中沉淀杂质以纯化单克隆抗体（mAb）的目的，目的是开发两步法抗体纯化方法。评价了CA诱导的蛋白质A柱洗脱池中的杂质沉淀，作为用于纯化mAb的抛光色谱技术的替代方法。评估包括pH，CA浓度，混合时间，mAb浓度，缓冲液系统和温育温度在内的参数对杂质去除，高分子量（HMW）形成和沉淀步骤收率的影响。 pH和CA浓度（而不是mAb浓度和缓冲液系统）都是可影响宿主细胞蛋白（HCP）清除率，HMW种类和产量的关键参数。在最佳条件下，CA沉淀将HCP和某些HMW物种去除到可接受的水平。 CA沉淀过程在15-25摄氏度时很稳定。对于本研究中测试的所有五个mAb，最佳CA浓度范围为0.5-1.0％，而pH范围为5.0至6.0。使用两个色谱步骤（蛋白质A捕获柱和离子交换抛光柱）与基于CA的杂质沉淀步骤相结合的纯化工艺可用作具有广泛等电点的mAb分子的可靠下游工艺。残留的CA可以通过随后的抛光阳离子交换色谱法有效地去除。 （C）2015美国化学工程师学会

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