Research and Early Development, Genentech Inc., 1 DNA Way, South San Francisco, CA 94080, USA.
Research and Early Development, Genentech Inc., 1 DNA Way, South San Francisco, CA 94080, USA.
J Pharm Biomed Anal. 2022 Sep 20;219:114928. doi: 10.1016/j.jpba.2022.114928. Epub 2022 Jul 5.
Nucleic acids are getting increased attention to fulfill unmet medical needs. The past five years have seen more than ten FDA approvals of nucleic acid based therapeutics. New analytical challenges have been posed in discovery, characterization, quality control and bioanalysis of therapeutic nucleic acids. Capillary electrophoresis (CE) has proven to be an efficient separation technique and has been widely used for analyzing oligonucleotides and nucleic acids. This review discusses the recent technical advances of CE in nucleic acid analysis such as polymeric matrices, separation conditions and detection methods, and the applications of CE to various therapeutic nucleic acids including antisense oligonucleotide (ASO), small interfering ribonucleic acid (siRNA), messenger RNA (mRNA), gene editing tools such as clustered regularly interspaced short palindromic repeats (CRISPR)-based gene and cell therapy, and other nucleic acid related therapeutics.
核酸越来越受到关注，以满足未满足的医疗需求。过去五年，FDA 批准了十多种基于核酸的疗法。在发现、表征、质量控制和治疗性核酸的生物分析方面，出现了新的分析挑战。毛细管电泳（CE）已被证明是一种有效的分离技术，已广泛用于分析寡核苷酸和核酸。本综述讨论了 CE 在核酸分析中的最新技术进展，如聚合物基质、分离条件和检测方法，以及 CE 在各种治疗性核酸中的应用，包括反义寡核苷酸（ASO）、小干扰核糖核酸（siRNA）、信使 RNA（mRNA）、基因编辑工具，如基于簇状规则间隔短回文重复序列（CRISPR）的基因和细胞治疗，以及其他核酸相关治疗。
