4.6 Article

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

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ELSEVIER
DOI: 10.1016/j.jpba.2021.114264

Keywords

Hydrogen peroxide; Cleaning validation; Vaccine; Yellow fever virus; Disinfection; Virus inactivation

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This study evaluated the inactivation performance of hydrogen peroxide on the yellow fever virus, showing promising results in reducing virus titre at different concentrations and exposure times. Hydrogen peroxide could be a potential disinfectant for yellow fever virus elimination, with varying optimum concentration and contact time depending on the application type.
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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