单克隆抗体纯化的病毒清除能力

IF 1.5 4区 生物学 Q4 BIOCHEMICAL RESEARCH METHODS
Kang Cai, Jennifer Anderson, Etienne Utiger, Gisela Ferreira
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引用次数: 0

摘要

病毒清除步骤是单克隆抗体纯化过程中的常规步骤,以防止产品受到潜在的病毒污染。为了证明这些步骤的病毒清除能力,通常会使用针对每个项目的特定产品原料和参数进行实验研究。然而,已发表的证据表明,在常用范围内,进料或工艺参数的变化对许多这些步骤的病毒清除能力影响不大。目前的调查证实,低 pH 值处理可有效灭活逆转录病毒,第二代病毒过滤器可清除副病毒,与单个抗体分子无关。我们的研究结果还显示,在蛋白质负荷和宿主细胞蛋白质含量的限制范围内,流过阴离子交换色谱法能有效清除逆转录病毒。这些步骤的累积病毒清除能力使内源性逆转录病毒样颗粒的超额清除安全系数达到 10,000 倍。这些结果进一步证明,使用基于先验知识的模块化病毒清除估算方法而不是重复实验是正确的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Viral clearance capability of monoclonal antibody purification

Viral clearance steps are routinely included in monoclonal antibody purification processes to safeguard product from potential virus contamination. These steps are often experimentally studied using product-specific feeds and parameters for each project to demonstrate viral clearance capability. However, published evidence suggests that viral clearance capability of many of these steps are not significantly impacted by variations in feed material or process parameter within commonly used ranges. The current investigation confirms robust retrovirus inactivation by low pH treatment and parvovirus removal by second-generation virus filters, independent to individual antibody molecules. Our results also reveal robust retrovirus removal by flowthrough anion exchange chromatography, inside the limits of protein load and host cell protein content. The cumulative viral clearance capability from these steps leads to an excess clearance safety factor of 10,000-fold for endogenous retrovirus-like particles. These results further justify the use of prior knowledge-based modular viral clearance estimation as opposed to repetitive experimentation.

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来源期刊
Biologicals
Biologicals 生物-生化研究方法
CiteScore
3.70
自引率
0.00%
发文量
39
审稿时长
48 days
期刊介绍: Biologicals provides a modern and multidisciplinary international forum for news, debate, and original research on all aspects of biologicals used in human and veterinary medicine. The journal publishes original papers, reviews, and letters relevant to the development, production, quality control, and standardization of biological derived from both novel and established biotechnologies. Special issues are produced to reflect topics of particular international interest and concern.Three types of papers are welcome: original research reports, short papers, and review articles. The journal will also publish comments and letters to the editor, book reviews, meeting reports and information on regulatory issues.
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