Analysis of therapeutic nucleic acids by capillary electrophoresis
Abstract
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.
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The CGE technique has been used for the isolation of nucleic acids of different lengths or different conformations in complex samples, such as analysis of plasmid supercoiled conformations, mRNA vaccine nucleic acid integrity and PolyA tail distribution, and human genome sequencing.
“The CGE technique has also been used for the isolation of nucleic acids of different lengths or different conformations in complex samples, such as the analysis of the purity of plasmid supercoiled conformations as well as the analysis of the nucleic acid integrity and PolyA tail distribution of mRNA vaccines, and it has also assisted in completing the human genome sequencing project [34].”
From Evaluation of the Efficacy of the Vaccine Production Process in Removing Residual Host Cell DNA from the Vero Cell Rabies Vaccine (2024) · cites this paper as [34]
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- Authors
- Wei, B., Goyon, A., & Zhang, K.
- Affiliations
- Genentech (US)
- Corresponding author
- Zhang, Kelly
- Venue
- Journal of Pharmaceutical and Biomedical Analysis
- Publisher
- Elsevier BV
- Published
- 2022-09
- Volume
- 219
- Pages
- 114928
- ISSN
- 0731-7085 (ISSN-L)
- OpenAlex
- W4284688865
- Cited by
- 50
- References
- 5
- Citations by year
- 2026: 9 · 2025: 20 · 2024: 11 · 2023: 7 · 2022: 2
- FWCI
- 0.89
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- Journal of Pharmaceutical and Biomedical Analysis (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Engineering › Biomedical Engineering › Microfluidic and Capillary Electrophoresis Applications
- Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
- Physical Sciences › Chemistry › Spectroscopy › Analytical Chemistry and Chromatography
- Keywords
- nucleic acid therapeutics, capillary electrophoresis, oligonucleotides, antisense oligonucleotides, siRNA, mRNA therapeutics, CRISPR gene editing, cell therapy, separation conditions, detection methods, quality control, bioanalysis
- MeSH terms
- Gene Editing, Nucleic Acids, Oligonucleotides, RNA, Electrophoresis, Capillary
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