Robustness testing of live attenuated rubella vaccine potency assay using fractional factorial design of experiments (CROSBI ID 583279)
Prilog sa skupa u zborniku | sažetak izlaganja sa skupa | međunarodna recenzija
Podaci o odgovornosti
Kutle, Leonida ; Pavlović, Nediljko ; Dorotić, Marko ; Zadro, Ivana ; Kapustić, Marijana ; Halassy, Beata
engleski
Robustness testing of live attenuated rubella vaccine potency assay using fractional factorial design of experiments
The potency assay for the freeze-dried live attenuated rubella vaccine is a cell culture based biological assay. The aim of our study was to perform the robustness testing of the rubella vaccine potency assay prior to validation. Seven intra-assay operating conditions that could have an effect on the assay performance were identified and their influence on the overall assay variability investigated by fractional factorial design of experiments (DoE). The robustness testing through DoE showed that the rubella vaccine potency assay is a robust assay. Critical operating conditions can be identified using DoE, which indicates that it is a suitable approach in bioassay robustness studies.
Potency assay validation ; Rubella vaccine ; Design of experiments ; Robustness
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Podaci o prilogu
2011.
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Podaci o matičnoj publikaciji
Podaci o skupu
Science and Standards Symposium on Biologics and Biotechnology: Advancing Quality Standards trough Analytics and Assays
pozvano predavanje
03.10.2011-06.10.2011
Seattle (WA), Sjedinjene Američke Države