Size analysis of residual host cell DNA in cell culture-produced vaccines by capillary gel electrophoresis
Abstract
Residual host cell DNA poses potential safety concerns for cell culture-derived vaccines or other biological products. In addition to the quantity of residual DNA, the size distribution is an important measure for determination of its associated risk factor. We have developed a new method for residual DNA size analysis, based on capillary gel electrophoresis (CGE) technology with sensitive laser induced fluorescence detection (LIF). The performance of this method was optimized through empirical selection of appropriate testing conditions and optimized conditions are presented. Examples are given to demonstrate the successful employment of this method for residual DNA size analysis of cell culture-produced vaccine samples.
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CGE is an effective method for high-precision and high-sensitivity analysis of HCD fragment size distribution.
“CGE is an effective method for high-precision and high-sensitivity analysis of HCD fragment size distribution [31].”
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 [31]
Shen et al. introduced and validated the CGE-LIF method for analyzing the size distribution of HCD in influenza viruses cultured in MDCK cells and confirmed that the detection limit of the method for nucleic acids can be lower than 1 ng/mL.
“Shen et al. introduced and validated the CGE-LIF method for analyzing the size distribution of HCD in influenza viruses cultured in MDCK cells and confirmed that the detection limit of the method for nucleic acids can be lower than 1 ng/mL [31].”
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 [31]
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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
- Authors
- Shen, X., Chen, X., Tabor, D. E., Liu, Y., Albarghouthi, M., Zhang, Y.-F., & Galinski, M. S.
- Venue
- Biologicals
- Publisher
- Elsevier BV
- Published
- 2013-05
- Volume
- 41
- Issue
- 3
- Pages
- 201-208
- ISSN
- 1045-1056 (ISSN-L)
- OpenAlex
- W2028585942
- Cited by
- 15
- References
- 0
- Citations by year
- 2025: 3 · 2024: 2 · 2022: 1 · 2019: 1 · 2018: 1 · 2016: 1 · 2015: 4 · 2014: 1 · 2013: 1
- FWCI
- 1.29
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Biologicals (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Engineering › Biomedical Engineering › Microfluidic and Capillary Electrophoresis Applications
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein purification and stability
- Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
- Keywords
- DNA fragment size distribution, cell culture-derived vaccine, capillary gel electrophoresis, laser-induced fluorescence detection, vaccine safety, biological products, method optimization
- MeSH terms
- Animals, Cell Line, Chlorocebus aethiops, DNA, Fluorescence, Influenza Vaccines, Vero Cells, Viral Vaccines, Reproducibility of Results, Polymerase Chain Reaction, Electrophoresis, Capillary, Respiratory Syncytial Virus Vaccines
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