Evaluation of hydrogen peroxide virucidal efficacy against yellow fever virus 17DD vaccine strain for application in a vaccine manufacturing industry

Ana Carolina Ferreira Balleste Ajorio, Vinicius Pessanha Rhodes, Anderson Peclat Rodrigues, Filipe Merces Moreira,Vanessa Alvaro Diniz,Josiane Machado Vieira Mattoso,Igor Barbosa da Silva, Daniel da Silva Guedes Junior,Marcelo Luiz Lima Brandao

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS(2021)

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摘要
The aim of this study was to evaluate the inactivation performance of hydrogen peroxide to the yellow fever virus 17DD vaccine strain, used for the production of attenuated yellow fever vaccine, in two matrixes: formulated yellow fever vaccine (FYV) and yellow fever viral suspension - active pharmaceutical ingredient (API). The samples were dried on stainless steel and exposed to hydrogen peroxide liquid (HPL) at concentrations of 30, 10, 3 and 1% for 20 and 60 min; and to hydrogen peroxide vapour (HPV) in an isolator. The exposure to HPL 30 and 10 %, within 20 min, reduced the virus titre at least 3.85 log(10) PFU/mL (74.8 %). During 60 min of exposure, the HPL 30, 10 and 3% reduced the virus titre by at least 3.18 log(10) PFU/mL (62.6 %). HPV exposure resulted in complete virus inactivation in FYV (>= 4.42 log(10) PFU/mL reduction) and for API samples 3.17 log(10) PFU/mL (64.3 %) reduction. Hydrogen peroxide showed to be a promising disinfectant for elimination of yellow fever virus. However, the optimum concentration and contact time will vary depending on the type of application, and as such may complement individual risk assessments of biological production processes. (C) 2021 Elsevier B.V. All rights reserved.
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关键词
Hydrogen peroxide,Cleaning validation,Vaccine,Yellow fever virus,Disinfection,Virus inactivation
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