Naslov
Robustness testing of live attenuated rubella vaccine potency assay using fractional factorial design of experiments

Autori
Kutle, Leonida ; Pavlović, Nediljko ; Dorotić, Marko ; Zadro, Ivana ; Kapustić, Marijana ; Halassy, Beata

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, pp prezentacija, znanstveni

Skup
Science and Standards Symposium on Biologics and Biotechnology: Advancing Quality Standards trough Analytics and Assays

Mjesto i datum
Seattle (WA), Sjedinjene Američke Države, 03.10.2011. - 06.10.2011

Vrsta sudjelovanja
Pozvano predavanje

Vrsta recenzije
Međunarodna recenzija

Ključne riječi
Potency assay validation ; Rubella vaccine ; Design of experiments ; Robustness

Sažetak
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.

Izvorni jezik
Engleski

Znanstvena područja
Biologija, Temeljne medicinske znanosti, Biotehnologija

POVEZANOST RADA