A collaborative study to examine the sensitivity and reproducibility of assays for the detection of DNA in biologicals derived from continuous cell lines
Abstract
This report describes the results of a collaborative study which was set up to examine the sensitivity and reproducibility of DNA assays performed by different laboratories. Fifteen laboratories analysed 12 samples containing different amounts of DNA and protein. The study revealed a high degree of variability between laboratories in determining the DNA content of the test samples.
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A collaborative study across 15 laboratories revealed that the hybridization assay was associated with a high degree of variability in determining rcDNA content.
“However, a collaborative study across 15 laboratories revealed that the hybridization assay was associated with a high degree of variability in determining rcDNA content (Robertson and Heath, 1992).”
From Comparative analysis of the performance of residual host cell DNA assays for viral vaccines produced in Vero cells (2019) · cites this paper as Robertson and Heath, 1992
Hybridization methods have a previously documented lack of robustness.
“Based on these limitations and previously documented lack of robustness of hybridization methods (Robertson and Heath, 1992), the waiving of this method from compendial monographs should be considered.”
From Comparative analysis of the performance of residual host cell DNA assays for viral vaccines produced in Vero cells (2019) · cites this paper as Robertson and Heath, 1992
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Vernay, O., Sarcey, E., Detrez, V., Abachin, E., Riou, P., Mouterde, B., Bonnevay, T., & Mallet, L. (2019) · Journal of Virological Methods · doi:10.1016/j.jviromet.2019.01.001 · Cited by 14 · see citing works
- Authors
- Robertson, J. S., & Heath, A. B.
- Affiliations
- National Institute for Biological Standards and Control (GB)
- Venue
- Biologicals
- Publisher
- Elsevier BV
- Published
- 1992-03
- Volume
- 20
- Issue
- 1
- Pages
- 73-81
- ISSN
- 1045-1056 (ISSN-L)
- OpenAlex
- W1975954344
- Cited by
- 8
- References
- 0
- Citations by year
- 2019: 2 · 2016: 1 · 2014: 1
- FWCI
- 0.00
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Biologicals (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
- Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Keywords
- DNA detection, immortalized cell lines, assay sensitivity, reproducibility, inter-laboratory variability, protein contamination
- MeSH terms
- Animals, Biological Products, Cell Line, DNA, Drug Contamination, Evaluation Studies as Topic, Nucleic Acid Hybridization, Proteins, Reference Standards, Sensitivity and Specificity, Reproducibility of Results, DNA Probes
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