拉曼光谱技术应用于动态结合能力分析
James W Beattie1,2, Ruth C Rowland-Jones3, Monika Farys3
1Department of Life Sciences, Imperial College London, London, UK.
Applied spectroscopy
|November 1, 2023
概括
拉曼光谱有效地监测生物治疗用蛋白质A树脂动态结合能力 (DBC). 这种先进的方法提供实时质量控制,超越了工业净化管道的传统技术.
科学领域:
- 生物制药制造业 生物制药制造业
- 分析化学 分析化学
- 过程分析技术 (PAT) 是一种分析技术.
背景情况:
- 蛋白A亲和色谱对于像抗体这样的生物治疗药物 (BTs) 的分离至关重要.
- 染色体树脂的动态结合能力 (DBC) 随着使用而下降,影响产品产量,并需要监管监测.
- 目前的DBC评估方法,如高性能亲和染色学 (HPAC),耗时,需要特定的校准,并提供有限的分析信息.
研究的目的:
- 评估拉曼光谱作为一种用于监测生物治疗净化过程中蛋白质A树脂DBC的新方法.
- 为了比较拉曼光谱法与已建立的方法 (如HPAC和UV染色学) 的疗效,用于DBC评估.
- 探索拉曼光谱技术在蛋白质度之外提供额外的质量控制信息的潜力.
主要方法:
- 使用拉曼光谱分析生物治疗负载期间的蛋白质A树脂.
- 在没有事先校准的情况下使用部分最小平方 (PLS) 分析与拉曼光谱一起用于DBC确定.
- 在96井板格式下进行离线分析,并考虑在线实现.
主要成果:
- 拉曼光谱在监测DBC方面显示出与HPAC和UV方法相比的有效性.
- 该技术从光谱中提供了化学信息,使得能够评估蛋白质聚合状态和结构.
- 拉曼光谱与PLS分析相结合,允许在没有特定校准的情况下进行DBC测定BT.
结论:
- 拉曼光谱是一种强大且改进的方法,用于在工业生物处理中监测DBC.
- 这种方法通过提供对蛋白质度,聚合和结构的见解,提供了增强的质量控制.
- 在线实现的潜力使拉曼光谱成为实时过程监控和优化的一个有价值的工具.
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