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Mitigating the risk of Zika virus contamination of raw materials and cell lines in the manufacture of biologicals

Ensuring the virological safety of biologicals is challenging due to the risk of viral contamination of raw materials and cell banks, and exposure during in-process handling to known and/or emerging viral pathogens. Viruses may contaminate raw materials and biologicals intended for human or veterina...

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Detalles Bibliográficos
Autores principales: Zmurko, Joanna, Vasey, Douglas B., Donald, Claire L., Armstrong, Alison A., McKee, Marian L., Kohl, Alain, Clayton, Reginald F.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Microbiology Society 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5882083/
https://www.ncbi.nlm.nih.gov/pubmed/29239715
http://dx.doi.org/10.1099/jgv.0.000995
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author Zmurko, Joanna
Vasey, Douglas B.
Donald, Claire L.
Armstrong, Alison A.
McKee, Marian L.
Kohl, Alain
Clayton, Reginald F.
author_facet Zmurko, Joanna
Vasey, Douglas B.
Donald, Claire L.
Armstrong, Alison A.
McKee, Marian L.
Kohl, Alain
Clayton, Reginald F.
author_sort Zmurko, Joanna
collection PubMed
description Ensuring the virological safety of biologicals is challenging due to the risk of viral contamination of raw materials and cell banks, and exposure during in-process handling to known and/or emerging viral pathogens. Viruses may contaminate raw materials and biologicals intended for human or veterinary use and remain undetected until appropriate testing measures are employed. The outbreak and expansive spread of the mosquito-borne flavivirus Zika virus (ZIKV) poses challenges to screening human- and animal -derived products used in the manufacture of biologicals. Here, we report the results of an in vitro study where detector cell lines were challenged with African and Asian lineages of ZIKV. We demonstrate that this pathogen is robustly detectable by in vitro assay, thereby providing assurance of detection of ZIKV, and in turn underpinning the robustness of in vitro virology assays in safety testing of biologicals.
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spelling pubmed-58820832018-04-05 Mitigating the risk of Zika virus contamination of raw materials and cell lines in the manufacture of biologicals Zmurko, Joanna Vasey, Douglas B. Donald, Claire L. Armstrong, Alison A. McKee, Marian L. Kohl, Alain Clayton, Reginald F. J Gen Virol Research Article Ensuring the virological safety of biologicals is challenging due to the risk of viral contamination of raw materials and cell banks, and exposure during in-process handling to known and/or emerging viral pathogens. Viruses may contaminate raw materials and biologicals intended for human or veterinary use and remain undetected until appropriate testing measures are employed. The outbreak and expansive spread of the mosquito-borne flavivirus Zika virus (ZIKV) poses challenges to screening human- and animal -derived products used in the manufacture of biologicals. Here, we report the results of an in vitro study where detector cell lines were challenged with African and Asian lineages of ZIKV. We demonstrate that this pathogen is robustly detectable by in vitro assay, thereby providing assurance of detection of ZIKV, and in turn underpinning the robustness of in vitro virology assays in safety testing of biologicals. Microbiology Society 2018-02 2017-12-14 /pmc/articles/PMC5882083/ /pubmed/29239715 http://dx.doi.org/10.1099/jgv.0.000995 Text en © 2018 The Authors http://creativecommons.org/licenses/by/4.0/ This is an open access article under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Zmurko, Joanna
Vasey, Douglas B.
Donald, Claire L.
Armstrong, Alison A.
McKee, Marian L.
Kohl, Alain
Clayton, Reginald F.
Mitigating the risk of Zika virus contamination of raw materials and cell lines in the manufacture of biologicals
title Mitigating the risk of Zika virus contamination of raw materials and cell lines in the manufacture of biologicals
title_full Mitigating the risk of Zika virus contamination of raw materials and cell lines in the manufacture of biologicals
title_fullStr Mitigating the risk of Zika virus contamination of raw materials and cell lines in the manufacture of biologicals
title_full_unstemmed Mitigating the risk of Zika virus contamination of raw materials and cell lines in the manufacture of biologicals
title_short Mitigating the risk of Zika virus contamination of raw materials and cell lines in the manufacture of biologicals
title_sort mitigating the risk of zika virus contamination of raw materials and cell lines in the manufacture of biologicals
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5882083/
https://www.ncbi.nlm.nih.gov/pubmed/29239715
http://dx.doi.org/10.1099/jgv.0.000995
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