Size distribution analysis of residual host cell DNA fragments in lentivirus by CGE-LIF
Abstract
During the production of cell and gene therapy products, residual host cell DNA (HCD) could cause safety risks of the biological products, and the longer the residual HCD fragment, the greater the risk to the human body. For this reason, it was necessary to develop an effective method for the size distribution analysis of residual HCD fragments with high accuracy and sensitivity. In this study, capillary gel electrophoresis with laser-induced fluorescence detector (CGE-LIF) was used to analyze the size distribution of residual HCD fragments in lentivirus products. The results confirmed that lentiviral RNA genome could interfere with the size distribution analysis of residual HCD fragments. By optimizing the amount of RNase I and digestion time in sample pretreatment process, the interfere of RNA genome could be avoided. The specificity, precision, accuracy, linear range, the detection of limit (LOD), and the quantification of limit (LOQ) of CGE-LIF method were also validated. The results showed that the CGE-LIF method had a good performance both in terms of specificity and reproducibility. The intra- and inter-day relative standard deviations of migration time and corrected peak area were all less than 1% and 2%, respectively. The 200 bp DNA marker had a good linearity between 50 and 1000 pg/ml. The LOD and LOQ of 200 bp DNA marker were 2.59 and 8.64 pg/ml, respectively. In addition, this method was successfully used to analyze the size distribution analysis of residual HCD f…
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There have been reports on the analysis of particle size distribution of residual HCD fragments in lentiviral products from different processes.
“There have been reports on the analysis of particle size distribution of residual HCD fragments in lentiviral products from different processes [33].”
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 [33]
Cites
High, K. A., & Roncarolo, M. G. (2019) · New England Journal of Medicine · doi:10.1056/nejmra1706910 · Cited by 555 · see citing works
Lentiviral Vectors in Gene Therapy: Their Current Status and Future Potential
Escors, D., & Breckpot, K. (2010) · Archivum Immunologiae et Therapiae Experimentalis · doi:10.1007/s00005-010-0063-4 · Cited by 344 · see citing works
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Li, J., Pan, R., Yue, F., Gao, T., Wu, X., Shi, L., Wang, Y., Zhao, D., Lan, Z., Chen, H., et al. (2024) · Vaccines · doi:10.3390/vaccines12121379 · Cited by 8 · see citing works
Self-citation
- Authors
- Wang, W., Gao, T., Luo, J., Guo, L., Li, X., Li, Y., & Chen, H.
- Affiliations
- SCIEX Beijing P. R. China
- National Institutes for Food and Drug Control (CN)
- National Medical Products Administration (CN)
- Corresponding author
- Li, Xiang
- Li, Yan
- Venue
- ELECTROPHORESIS
- Publisher
- Wiley
- Published
- 2022-11-21
- Volume
- 44
- Issue
- 3-4
- Pages
- 462-471
- ISSN
- 0173-0835 (ISSN-L)
- 1522-2683
- OpenAlex
- W4308679411
- Cited by
- 7
- References
- 2
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 3
- FWCI
- 0.75
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Electrophoresis (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Virus-based gene therapy research
- Physical Sciences › Engineering › Biomedical Engineering › Microfluidic and Capillary Electrophoresis Applications
- Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
- Keywords
- lentivirus, cell and gene therapy products, product safety, method validation
- MeSH terms
- DNA, Genetic Markers, Humans, Reproducibility of Results, Lentivirus, Polymerase Chain Reaction, Electrophoresis, Capillary
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