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首页> 外文期刊>Electrophoresis: The Official Journal of the International Electrophoresis Society >Capillary gel electrophoresis of therapeutic oligonucleotides--analysis of single- and double-stranded forms.
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Capillary gel electrophoresis of therapeutic oligonucleotides--analysis of single- and double-stranded forms.

机译：治疗性寡核苷酸的毛细管电泳-单链和双链形式的分析。

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Recently, several therapeutic double-stranded (ds) oligonucleotides (ODNs) are in pharmaceutical development. During quality control, these therapeutic molecules have to be characterized with respect to their identity, their content and their impurity profile. It follows that the ds molecule as well as its process- and product-related impurities have to be quantified. The single strands are considered as process as well as product-related impurities in the ds drug substance. Applying well known, conventional, single-base resolution CE-CGE systems developed for the quality control of single-stranded antisense ODNs in the early 1990s, it turned out that the ds ODNs under investigation are migrating in broad, splitted peaks between the peaks reaction zones are observed. It follows that the quantification of the single strands in the drug substance as well as quantification of other product-related impurities, e.g. n-1; n-2 (loss of one and two bases (n), respectively) etc., are not possible without adaptation of the test system. The paper shows how the test system was adjusted in order to determine single-stranded strands as well as ds strands next to each other quantitatively in the ds drug substance under investigation.
机译：最近，几种治疗性双链（ds）寡核苷酸（ODN）正在药物开发中。在质量控制过程中，必须根据其身份，含量和杂质概况对这些治疗性分子进行表征。因此，必须对ds分子及其与过程和产品有关的杂质进行定量。单链被认为是ds原料药中的过程以及与产品相关的杂质。应用众所周知的，常规的，单碱基分辨率的CE-CGE系统在1990年代初为单链反义ODN的质量控制开发的结果表明，所研究的ds ODN正在峰反应之间的宽阔，分离峰中迁移。区域。随之而来的是对原料药中单链的定量以及与产品相关的其他杂质（例如杂质）的定量。 n-1;如果不调整测试系统，则无法实现n-2（分别损失一个和两个碱基（n））等。本文显示了如何调整测试系统，以便确定所研究的ds药物中的单链和ds链彼此相邻。

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