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Recent advances in therapeutic nucleic acids and their analytical methods
Jadera Talap1, Jing Zhao2, Minzhe Shen1
1Institute of Drug Metabolism and Pharmaceutical Analysis, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, Zhejiang 310058, China.
Journal of Pharmaceutical and Biomedical Analysis
|September 27, 2021
Summary
Therapeutic nucleic acids, including antisense oligonucleotides and mRNA, offer gene-level targeting for diseases. Advances in synthesis and delivery accelerate development, requiring robust analytical methods for quality control and clinical research.
Area of Science:
- Biotechnology
- Molecular Biology
- Pharmacology
Background:
- Therapeutic nucleic acids, including antisense oligonucleotides (ASO), RNA interference (RNAi), mRNA, and aptamers, function at the gene level.
- Chemical synthesis and delivery material advancements have rapidly accelerated the development of nucleic acid-based therapeutics.
- Seventeen nucleic acid-based therapeutics are currently approved by the FDA or EMA, highlighting their growing clinical significance.
Purpose of the Study:
- To review different classes of therapeutic nucleic acids and their applications.
- To summarize nucleic acid-based therapeutics commercialized between 2019 and the present.
- To discuss and evaluate analytical methods for quality control and clinical research of these therapeutics.
Main Methods:
- Review of different classes of therapeutic nucleic acids (ASO, RNAi, mRNA, aptamers).
- Analysis of commercialized nucleic acid therapeutics from 2019 to present.
- Discussion of analytical techniques including liquid chromatography, capillary gel electrophoresis (CGE), and hybridization enzyme-linked immunosorbent assay (ELISA).
Main Results:
- Identification of various therapeutic nucleic acid classes with significant application prospects.
- Overview of recently approved and commercialized nucleic acid-based drugs.
- Summary of current analytical methods, highlighting their advantages and limitations.
Conclusions:
- Therapeutic nucleic acids represent a rapidly advancing field with significant clinical impact.
- Robust analytical methods are crucial for ensuring the quality and efficacy of these novel therapeutics.
- Future development of analytical techniques is essential to meet the evolving demands of nucleic acid-based drug development.
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