Since 2016, eight new oligonucleotide therapies have been approved which has led to increased interest in oligonucleotide analysis. There is a particular need for powerful bioanalytical tools to study the metabolism and biotransformation of these molecules. This review provides the background on the biological basis of these molecules as currently used in therapies. The article also reviews the current state of analytical methodology including state of the art sample preparation techniques, liquid chromatography-mass spectrometry methods, and the current limits of detection/quantitation. Finally, the article summarizes the challenges in oligonucleotide bioanalysis and provides future perspectives for this emerging field. © 2020 John Wiley & Sons Ltd.

中文翻译：

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通过液相色谱-质谱法对寡核苷酸治疗药物进行生物分析和生物转化

自 2016 年以来，已经批准了八种新的寡核苷酸疗法，这导致对寡核苷酸分析的兴趣增加。特别需要强大的生物分析工具来研究这些分子的代谢和生物转化。本综述提供了目前用于治疗的这些分子的生物学基础背景。该文章还回顾了分析方法的当前状态，包括最先进的样品制备技术、液相色谱-质谱法以及当前的检测/定量限制。最后，文章总结了寡核苷酸生物分析面临的挑战，并为这一新兴领域提供了未来展望。© 2020 约翰威利父子公司。