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在早期药物发现中对寡核酸的快速和灵活的分析特征

Kathrin Stavenhagen¹, Manasses Jora¹, Carina Leandersson¹

¹Medicinal Chemistry, Research and Early Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Pepparedsleden 1, SE-431 83 Mölndal, Sweden.

Journal of chromatography. A

|November 13, 2025

概括

快速液体染色学-质谱法方法加速治疗性寡核酸的分析,增强早期药物发现. 这些技术为反感性寡核酸和小干扰RNA的发展提供了快速的纯度评估和杂质分析.

科学领域:

生物化学和分子生物学
分析化学分析化学
制药科学制药科学

背景情况:

反感性寡核酸 (ASOs) 和小干扰RNA (siRNA) 是基因表达调节的关键RNA向技术.
早期药物发现需要广泛的合成和严格的分析特征的寡核酸纯度评估.
当前的分析方法和数据处理在寡核酸开发中对高通量选构成瓶.

研究的目的:

开发和介绍快速液体染色体质谱法 (LC-MS) 方法用于治疗性寡核酸的分析特征.
为了在早期药物发现中快速确认分子重量,纯度评估和对寡核酸的杂质分析.
解决针对寡核酸合成和测试的高通量分析解决方案的瓶问题.

主要方法:

开发了两种不同的LC-MS方法:高通量选 (HTS) 方法和深入表征方法.
HTS方法允许每天对数百个寡核酸样本进行快速纯度检查,适用于分数分析.
深度方法提供了详细的纯度分析和杂质分析,以进行全面的表征.

主要成果:

开发的LC-MS方法提供了快速而准确的分子量确认,纯度评估和杂质分析.
该HTS方法证明了每天分析数百个样本的能力,显著提高了吞吐量.
这两种方法都包含半自动化数据处理和报告工具,以实现高效的数据处理和结果交付.

结论:

提出的LC-MS方法为早期的寡核酸药物发现提供了快速灵活的分析解决方案.
这些方法支持高通量查和深入表征,加速了寡核酸治疗药物的开发.
集成自动化数据处理可以提高寡核酸开发程序中分析结果的效率和质量.

关键词:

分析性表征分析性表征杂质是指不纯净的东西.离子对逆相液态染色学离子对逆相液态染色学质谱测量质量谱测量有氧核酸类的纯度分析是一种纯度分析.逆相液态染色学逆相液态染色学

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