Evaluation of hydrogen peroxide efficacy against AZD1222 chimpanzee adenovirus strain in the recombinant COVID-19 vaccine for application in cleaning validation in a pharmaceutical manufacturing industry

Detalhes bibliográficos
Autor(a) principal: Ajorio, A. C. F. B.
Data de Publicação: 2021
Outros Autores: Rhodes, V. P., Rodrigues, A. P., Diniz, V. A., Mattoso, J. M. V., Silva, I. B. da, D‘Aiuto, D. M. M., Brandão, M. L. L.
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/50682
Resumo: Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.
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spelling Ajorio, A. C. F. B.Rhodes, V. P.Rodrigues, A. P.Diniz, V. A.Mattoso, J. M. V.Silva, I. B. daD‘Aiuto, D. M. M.Brandão, M. L. L.2022-01-09T00:52:20Z2022-01-09T00:52:20Z2021AJORIO, A. C. F. B. et al. Evaluation of hydrogen peroxide efficacy against AZD1222 chimpanzee adenovirus strain in the recombinant COVID-19 vaccine for application in cleaning validation in a pharmaceutical manufacturing industry. Letters in Applied Microbiology, p. 1-7, Dec. 2021.0266-8254https://www.arca.fiocruz.br/handle/icict/5068210.1111/lam.13635engThe Society for Applied MicrobiologyBiopharmaceuticalsPharmaceuticalsQuality controlVaccinesVirusesCOVID-19Evaluation of hydrogen peroxide efficacy against AZD1222 chimpanzee adenovirus strain in the recombinant COVID-19 vaccine for application in cleaning validation in a pharmaceutical manufacturing industryinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleFundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.This study aimed to evaluate the performance of hydrogen peroxide vapour (HPV) to inactivate the chimpanzee adenovirus AZD1222 vaccine strain used in the production of recombinant COVID-19 vaccine for application in cleaning validation in pharmaceutical industries production areas. Two matrixes were tested: formulated recombinant COVID-19 vaccine (FCV) and active pharmaceutical ingredient (API). The samples were dried on stainless steel and exposed to HPV in an isolator. One biological indicator with population >106 Geobacillus stearothermophilus spores was used to validate the HPV decontamination cycle as standard. HPV exposure resulted in complete virus inactivation in FVC (≥5 03 log10) and API (≥6 40 log10), showing HPV efficacy for reducing chimpanzee adenovirus AZD1222 vaccine strain. However, the optimum concentration and contact time will vary depending on the type of application. Future decontamination studies scaling up the process to the recombinant COVID-19 vaccine manufacturing areas are necessary to evaluate if the HPV will have the same or better virucidal effectivity in each specific production area. In conclusion, HPV showed efficacy for reducing AZD1222 chimpanzee adenovirus strain and can be a good choice for pharmaceutical industries facilities disinfection during recombinant COVID-19 vaccine production.info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83134https://www.arca.fiocruz.br/bitstream/icict/50682/1/license.txt0ab46789d568c4ba27c7b5d29a9fe9c4MD51ORIGINALAjorio_A.C.F.B._etal_BIOMANGUINHOS_COVID-19_2021.pdfAjorio_A.C.F.B._etal_BIOMANGUINHOS_COVID-19_2021.pdfapplication/pdf469197https://www.arca.fiocruz.br/bitstream/icict/50682/2/Ajorio_A.C.F.B._etal_BIOMANGUINHOS_COVID-19_2021.pdf75ff08f42c7a0a5d31b5bd2eba8b2a32MD52icict/506822022-01-08 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dc.title.pt_BR.fl_str_mv Evaluation of hydrogen peroxide efficacy against AZD1222 chimpanzee adenovirus strain in the recombinant COVID-19 vaccine for application in cleaning validation in a pharmaceutical manufacturing industry
title Evaluation of hydrogen peroxide efficacy against AZD1222 chimpanzee adenovirus strain in the recombinant COVID-19 vaccine for application in cleaning validation in a pharmaceutical manufacturing industry
spellingShingle Evaluation of hydrogen peroxide efficacy against AZD1222 chimpanzee adenovirus strain in the recombinant COVID-19 vaccine for application in cleaning validation in a pharmaceutical manufacturing industry
Ajorio, A. C. F. B.
Biopharmaceuticals
Pharmaceuticals
Quality control
Vaccines
Viruses
COVID-19
title_short Evaluation of hydrogen peroxide efficacy against AZD1222 chimpanzee adenovirus strain in the recombinant COVID-19 vaccine for application in cleaning validation in a pharmaceutical manufacturing industry
title_full Evaluation of hydrogen peroxide efficacy against AZD1222 chimpanzee adenovirus strain in the recombinant COVID-19 vaccine for application in cleaning validation in a pharmaceutical manufacturing industry
title_fullStr Evaluation of hydrogen peroxide efficacy against AZD1222 chimpanzee adenovirus strain in the recombinant COVID-19 vaccine for application in cleaning validation in a pharmaceutical manufacturing industry
title_full_unstemmed Evaluation of hydrogen peroxide efficacy against AZD1222 chimpanzee adenovirus strain in the recombinant COVID-19 vaccine for application in cleaning validation in a pharmaceutical manufacturing industry
title_sort Evaluation of hydrogen peroxide efficacy against AZD1222 chimpanzee adenovirus strain in the recombinant COVID-19 vaccine for application in cleaning validation in a pharmaceutical manufacturing industry
author Ajorio, A. C. F. B.
author_facet Ajorio, A. C. F. B.
Rhodes, V. P.
Rodrigues, A. P.
Diniz, V. A.
Mattoso, J. M. V.
Silva, I. B. da
D‘Aiuto, D. M. M.
Brandão, M. L. L.
author_role author
author2 Rhodes, V. P.
Rodrigues, A. P.
Diniz, V. A.
Mattoso, J. M. V.
Silva, I. B. da
D‘Aiuto, D. M. M.
Brandão, M. L. L.
author2_role author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Ajorio, A. C. F. B.
Rhodes, V. P.
Rodrigues, A. P.
Diniz, V. A.
Mattoso, J. M. V.
Silva, I. B. da
D‘Aiuto, D. M. M.
Brandão, M. L. L.
dc.subject.other.pt_BR.fl_str_mv Biopharmaceuticals
Pharmaceuticals
Quality control
Vaccines
Viruses
COVID-19
topic Biopharmaceuticals
Pharmaceuticals
Quality control
Vaccines
Viruses
COVID-19
description Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.
publishDate 2021
dc.date.issued.fl_str_mv 2021
dc.date.accessioned.fl_str_mv 2022-01-09T00:52:20Z
dc.date.available.fl_str_mv 2022-01-09T00:52:20Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv AJORIO, A. C. F. B. et al. Evaluation of hydrogen peroxide efficacy against AZD1222 chimpanzee adenovirus strain in the recombinant COVID-19 vaccine for application in cleaning validation in a pharmaceutical manufacturing industry. Letters in Applied Microbiology, p. 1-7, Dec. 2021.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/50682
dc.identifier.issn.pt_BR.fl_str_mv 0266-8254
dc.identifier.doi.none.fl_str_mv 10.1111/lam.13635
identifier_str_mv AJORIO, A. C. F. B. et al. Evaluation of hydrogen peroxide efficacy against AZD1222 chimpanzee adenovirus strain in the recombinant COVID-19 vaccine for application in cleaning validation in a pharmaceutical manufacturing industry. Letters in Applied Microbiology, p. 1-7, Dec. 2021.
0266-8254
10.1111/lam.13635
url https://www.arca.fiocruz.br/handle/icict/50682
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv The Society for Applied Microbiology
publisher.none.fl_str_mv The Society for Applied Microbiology
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv https://www.arca.fiocruz.br/bitstream/icict/50682/1/license.txt
https://www.arca.fiocruz.br/bitstream/icict/50682/2/Ajorio_A.C.F.B._etal_BIOMANGUINHOS_COVID-19_2021.pdf
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repository.name.fl_str_mv Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv repositorio.arca@fiocruz.br
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