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首页> 外文期刊>Biotechnology Progress >Multipronged Approach to Managing Beta-Glucan Contaminants in the Downstream Process: Control of Raw Materials and Filtration with Charge-Modified Nylon 6,6 Membrane Filters
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Multipronged Approach to Managing Beta-Glucan Contaminants in the Downstream Process: Control of Raw Materials and Filtration with Charge-Modified Nylon 6,6 Membrane Filters

机译：在下游过程中管理β-葡聚糖污染物的多管齐下方法：使用电荷改性尼龙6,6膜过滤器控制原材料和过滤

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摘要

(1→3)-β-D-Glucans (beta-glucans) have been found in raw materials used in the manufacture of recombinant therapeutics. Because of their biological activity, beta-glucans are considered process contaminants and consequently their level in the product needs to be controlled. Although beta-glucans introduced into the cell culture process can readily be removed by bind-and-elute chromatography process steps, beta-glucans can also be introduced into the purification process through raw materials containing beta-glucans as well as leachables from filters made from cellulose. This article reports a multipronged approach to managing the beta-glucan contamination in the downstream process. Raw material screening and selection can be used to effectively limit the level of beta-glucan introduced into the downstream process. Placement of a cellulosic filter upstream of the last bind-and-elute column step or effective preuse flushing can also limit the level of contaminant introduced. More importantly, this article reports the active removal of beta-glucan from the downstream process when necessary. It was discovered that the Posidyne filter, a charge-modified nylon 6,6 membrane filter, was able to effectively remove beta-glucans from buffers at relatively low pH and salt concentrations. An approach of using low beta-glucan buffer components combined with filtration of the buffer with a Posidyne membrane has been successfully demonstrated at preparative scale. Additionally, the feasibility of active removal of beta-glucan from in-process product pools by Posidyne membrane filtration has also been demonstrated. Based on the data presented, a mechanism for binding is proposed, as well as a systematic approach for sizing of the Posidyne filter.
机译：在用于制备重组治疗剂的原料中发现了（1→3）-β-D-葡聚糖（β-葡聚糖）。由于其生物活性，β-葡聚糖被认为是过程污染物，因此需要控制其在产品中的含量。尽管可以通过结合洗脱色谱法轻松除去引入细胞培养过程中的β-葡聚糖，但也可以通过含有β-葡聚糖以及可从过滤器制成的滤器中提取的原料将β-葡聚糖引入纯化过程。纤维素。本文报告了在下游过程中管理β-葡聚糖污染的多管齐下的方法。原料筛选和选择可用于有效限制引入下游工艺的β-葡聚糖水平。将纤维素过滤器放置在最后一个结合洗脱柱步骤的上游或有效的使用前冲洗也可以限制引入的污染物水平。更重要的是，本文报道了必要时从下游过程中主动去除β-葡聚糖的情况。已发现，Posidyne过滤器（一种电荷改性的尼龙6,6膜过滤器）能够在相对较低的pH和盐浓度下从缓冲液中有效去除β-葡聚糖。在制备规模上已成功地证明了使用低β-葡聚糖缓冲液成分并用Posidyne膜过滤缓冲液的方法。此外，还已经证明了通过Posidyne膜过滤从过程中的产品池中主动去除β-葡聚糖的可行性。基于提供的数据，提出了一种绑定机制，以及一种用于确定Posidyne滤波器大小的系统方法。

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