Advanced Virus Detection Technologies Interest Group (AVDTIG): Efforts on High Throughput Sequencing (HTS) for Virus Detection
Abstract
Several nucleic-acid based technologies have recently emerged with capabilities for broad virus detection. One of these, high throughput sequencing, has the potential for novel virus detection because this method does not depend upon prior viral sequence knowledge. However, the use of high throughput sequencing for testing biologicals poses greater challenges as compared to other newly introduced tests due to its technical complexities and big data bioinformatics. Thus, the Advanced Virus Detection Technologies Users Group was formed as a joint effort by regulatory and industry scientists to facilitate discussions and provide a forum for sharing data and experiences using advanced new virus detection technologies, with a focus on high throughput sequencing technologies. The group was initiated as a task force that was coordinated by the Parenteral Drug Association and subsequently became the Advanced Virus Detection Technologies Interest Group to continue efforts for using new technologies for detection of adventitious viruses with broader participation, including international government agencies, academia, and technology service providers.
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The IVV assay takes between 14 to 28 days to complete.
“An additional challenge is that the IVV assay takes between 14 to 28 days to complete 38,53,59,60 and is not amenable to the rapid release required of some ATMP products.”
From Viral contamination in biologic manufacture and implications for emerging therapies (2020) · cites this paper as [59]
Cites
Victoria, J. G., Wang, C., Jones, M. S., Jaing, C., McLoughlin, K., Gardner, S., & Delwart, E. L. (2010) · Journal of Virology · doi:10.1128/jvi.02690-09 · Cited by 342 · see citing works
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Goodacre, N., Aljanahi, A., Nandakumar, S., Mikailov, M., & Khan, A. S. (2018) · mSphere · doi:10.1128/mspheredirect.00069-18 · Cited by 253 · see citing works
Self-citationViral contamination in biologic manufacture and implications for emerging therapies
Barone, P. W., Wiebe, M. E., Leung, J. C., Hussein, I. T. M., Keumurian, F. J., Bouressa, J., Brussel, A., Chen, D., Chong, M., Dehghani, H., et al. (2020) · Nature Biotechnology · doi:10.1038/s41587-020-0507-2 · Cited by 212 · see citing works
- Authors
- Khan, A. S., Vacante, D. A., Cassart, J.-P., Ng, S. H. S., Lambert, C., Charlebois, R. L., & King, K. E.
- Affiliations
- Center for Biologics Evaluation and Research (US)
- Janssen Research & Development (United States) (US)
- GlaxoSmithKline (Belgium) (BE)
- Sanofi (Canada) (CA)
- United States Food and Drug Administration (US)
- Venue
- PDA Journal of Pharmaceutical Science and Technology
- Publisher
- Parenteral Drug Association, Inc.
- Published
- 2016-09-04
- Volume
- 70
- Issue
- 6
- Pages
- 591-595
- ISSN
- 1079-7440 (ISSN-L)
- OpenAlex
- W2508197536
- Cited by
- 25
- References
- 1
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 2 · 2023: 3 · 2022: 2 · 2021: 1 · 2020: 4 · 2019: 1 · 2018: 6 · 2017: 1
- FWCI
- 1.39
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- PDA Journal of Pharmaceutical Science and Technology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Genomics and Phylogenetic Studies
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Viral Infectious Diseases and Gene Expression in Insects
- Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
- Keywords
- next-generation sequencing, virus detection, adventitious viruses, biological products, regulatory science, bioinformatics, parenteral products
- MeSH terms
- Public Opinion, Technology, Pharmaceutical, Viruses, Computational Biology, High-Throughput Nucleotide Sequencing
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