通过大小排斥染色体对单克隆抗体的持续监测显示了系统适应性参数和柱子老化之间的相关性
Kai-Wei Wu1, Tse-Hong Chen2, Teng-Chieh Yang2
1Department of Pharmaceutics and Drug Delivery, The University of Mississippi, University, MS 38677, USA.
Journal of pharmaceutical and biomedical analysis
|August 4, 2023
概括
监测尺寸排除色谱 (SEC) 列对于生物产品的纯度至关重要. 在1000次注射后,尾部系数和峰值宽度等关键性能指标降低,分辨率和板数减少,影响了试验可靠性.
科学领域:
- 分析化学 分析化学
- 生物制药学分析
- 染色学科学 染色学科学
背景情况:
- 尺寸排除色谱 (SEC) 对于评估生物分子纯度至关重要.
- 对于监管合规性和数据可重复性而言,对SEC列的一致监控至关重要.
- 系统适用性参数 (SSP) 对于评估SEC测试性能至关重要.
研究的目的:
- 通过多次注射来评估SEC列的性能和降解.
- 为了建立一个定量理解如何列性能变化与使用.
- 为了确定关键的系统适用性参数,表明列性能下降.
主要方法:
- 为了测试,使用了19个SEC列 (水流水位BEH200).
- 采用内部单克隆抗体进行列评价.
- 使用系统适用性参数 (SSP) 监控性能,包括分辨率,板数,尾部系数,不对称系数,化时间,峰值宽度和峰值高度.
主要成果:
- 一个通用线性模型表明,随着注射次数的增加,性能下降.
- 化时间,峰值宽度,不对称性因子和尾巴因子显示出日益增长的趋势.
- 峰值高度,USP分辨率和USP车牌数量呈现下降趋势.
- 1000次注射后,尾部系数和峰幅增加了10%以上,分辨率和板数减少了10%以上.
结论:
- 在重复使用 (1000次注射) 后,SEC列的性能显著降低.
- 退化可以通过特定系统适用性参数的变化来量化.
- 对SEC列的持续监测是必要的,以确保生物制药分析的可靠性.
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