Citation: Meichen Li, Xiangjun Meng. Recent advances in bioanalytical technologies for oligonucleotide therapeutics: Technical progress and methodological challenges[J]. Chinese Chemical Letters, ;2026, 37(10): 112501. doi: 10.1016/j.cclet.2026.112501 shu

Recent advances in bioanalytical technologies for oligonucleotide therapeutics: Technical progress and methodological challenges

Meichen Li ,
Xiangjun Meng ^*,

School of Pharmaceutical Science and Technology, Faculty of Medicine, Tianjin University, Tianjin 300072, China

mengxj_23@tju.edu.cn

Received Date: 31 July 2025
Revised Date: 28 November 2025
Accepted Date: 5 February 2026
Available Online: 5 February 2026

Figures(5)

Oligonucleotide therapy offers a promising approach for the treatment of various diseases by specifically targeting genes or pathogenic molecules with therapeutic oligonucleotides, demonstrating significant therapeutic efficacy and application potential. To date, the Food and Drug Administration (FDA) has approved over 20 oligonucleotide-based drugs. Pharmacokinetics plays a critical role in the regulatory approval of these drugs, which necessitates robust bioanalytical techniques. In this review, we first elucidate the mechanisms and representative drugs associated with different classes of therapeutic oligonucleotides, alongside an overview of their commonly used delivery systems. Subsequently, we provide a systematic overview of current bioanalytical methodologies, including sample preparation, separation, and detection, and highlight advantages, recent advancements, and challenges. Finally, we discuss future directions for analytical technique development for oligonucleotides.
- Therapeutic oligonucleotides,
- Bioanalysis,
- Sample preparation,
- Separation,
- Quantitative detection
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