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

• Published in: Journal of pharmaceutical and biomedical analysis 2021-09, Vol.204, p.114264-114264, Article 114264
• Main Authors: Ferreira Ballestê Ajorio, Ana Carolina, Pessanha Rhodes, Vinícius, Peclat Rodrigues, Anderson, Mercês Moreira, Filipe, Alvaro Diniz, Vanessa, Machado Vieira Mattoso, Josiane, Barbosa da Silva, Igor, da Silva Guedes Junior, Daniel, Lima Brandão, Marcelo Luiz
• Format: Article
• Language: English
• Subjects: Cleaning validation; Disinfection; Hydrogen peroxide; Vaccine; Virus inactivation; Yellow fever virus
• ISSN: 0731-7085; 1873-264X
• DOI: 10.1016/j.jpba.2021.114264

[Display omitted] •Exposure to HPL ≥ 10 % for 20 min was efficient for yellow fever virus disinfection.•Exposure to HPV was efficient for disinfection of yellow fever virus in FYV.•Exposure to HPV wasn’t efficient for disinfection of yellow fever virus in API.•Residual H2O2 caused damage to cells and must be removed to before titration.•Presence of organic material and catalase reduced the efficacy of HPV disinfection. 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 log10 PFU/mL (74.8 %). During 60 min of exposure, the HPL 30, 10 and 3% reduced the virus titre by at least 3.18 log10 PFU/mL (62.6 %). HPV exposure resulted in complete virus inactivation in FYV (≥ 4.42 log10 PFU/mL reduction) and for API samples 3.17 log10 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.