Key Technologies for Quality Control of Oligonucleotide Drugs

doi:10.19803/j.1672-8629.20240806

Abstract

Abstract: Objective To review the basic data and quality control methods of oligonucleotide drugs in order to provide a reference for quality control of oligonucleotide drugs. Methods By searching related literature and databases at home and abroad, the methods of analysis of related substances, structural characterization, and quantification of oligonucleotides were summarized. Results There were three types of oligonucleotide drugs that had been listed: antisense oligonucleotide, small interfering RNA, and aptamer. Their domestic quality control guidelines mainly referred to foreign guidelines. Ion-pair reverse phase chromatography, ion exchange chromatography, and mass spectrometry were commonly used for quality control of oligonucleotide drugs. Other analysis techniques had their own advantages. Conclusion Significant progress has been made in quality control of oligonucleotide drugs. However, China lacks specific guidelines. Furthermore, there are several problems with the current oligonucleotide drug analysis techniques. To offer strong technical support for quality control of oligonucleotide drugs, research and the development of novel techniques are required.

Key words: Oligonucleotides, Antisense Oligonucleotide(ASO), Small Interfering RNA(siRNA), Aptamer, Quality Control, Related Substance, Liquid Chromatography, Mass Spectrometry, Liquid Chromatography-Mass Spectrometry

CLC Number:

R917

LIU Bo, YUAN Yanan, WANG Yue, CHENG Shuqian, LU Zhiguo, FAN Huihong, SUN Huimin. Key Technologies for Quality Control of Oligonucleotide Drugs[J]. Chinese Journal of Pharmacovigilance, 2025, 22(1): 1-9.

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