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Pregled bibliografske jedinice broj: 470162

Application of Fractional Factorial Design of Experiments to Live Attenuated Measles Vaccine Potency Assay Robustness Testing


Kutle, Leonida; Zadro, Ivana; Božić, Tamara; Kapustić, Marijana; Ivančić, Blaženka; Pavlović, Nediljko
Application of Fractional Factorial Design of Experiments to Live Attenuated Measles Vaccine Potency Assay Robustness Testing // Biopharmaceutical Emerging Best Practices Association (BEBPA)'s Annual Bioassay Conference
Rim, Italija, 2009. (poster, međunarodna recenzija, neobjavljeni rad, znanstveni)


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Naslov
Application of Fractional Factorial Design of Experiments to Live Attenuated Measles Vaccine Potency Assay Robustness Testing

Autori
Kutle, Leonida ; Zadro, Ivana ; Božić, Tamara ; Kapustić, Marijana ; Ivančić, Blaženka ; Pavlović, Nediljko

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, neobjavljeni rad, znanstveni

Skup
Biopharmaceutical Emerging Best Practices Association (BEBPA)'s Annual Bioassay Conference

Mjesto i datum
Rim, Italija, 30.09.-02.10.2009

Vrsta sudjelovanja
Poster

Vrsta recenzije
Međunarodna recenzija

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

Sažetak
The potency assay for the freeze-dried live attenuated measles vaccine is a cell culture based biological assay. Susceptible cell cultures prepared in microtiter plates are infected by a series of virus dilutions and the occurrence of the cytopathic effect is measured. Various intra-assay operating conditions could have an effect on the assay performance, and consequently on the results of the assay. To revise the standard operating conditions and enhance the flexibility of the assay performance, the robustness testing of the measles vaccine potency assay was performed. Six factors which are considered to be the potential sources of the assay variability were identified, and their values for the two experimental levels were defined. Fractional factorial design of experiments (DOE) with resolution IV (26-2 (IV)) was applied, and the specification for 16 experiments was obtained. The examined factors were the cell passage, the age of cells within the passage, the foetal bovine serum manufacturer, the microtiter plates manufacturer, the pre-incubation time of cells in the microtiter plates, and the incubation time of the microtiter plates during the assay. The effect of each factor was compared to the overall assay variability obtained from all experiments, and to the European Pharmacopoeia potency assay requirements. It was shown that five out of six factors have no effect on the assay variability. The effect of the remaining factor, the age of cells within a passage, was shown to be very subtle and considerably smaller in comparison to the assay variability requirements proposed by the European Pharmacopoeia. The robustness testing through DOE showed that the measles vaccine potency assay is a very robust method which can be performed in all of the assay conditions examined in this study.

Izvorni jezik
Engleski

Znanstvena područja
Biologija, Temeljne medicinske znanosti, Biotehnologija



POVEZANOST RADA


Ustanove
Imunološki zavod d.d.

Citiraj ovu publikaciju

Kutle, Leonida; Zadro, Ivana; Božić, Tamara; Kapustić, Marijana; Ivančić, Blaženka; Pavlović, Nediljko
Application of Fractional Factorial Design of Experiments to Live Attenuated Measles Vaccine Potency Assay Robustness Testing // Biopharmaceutical Emerging Best Practices Association (BEBPA)'s Annual Bioassay Conference
Rim, Italija, 2009. (poster, međunarodna recenzija, neobjavljeni rad, znanstveni)
Kutle, L., Zadro, I., Božić, T., Kapustić, M., Ivančić, B. & Pavlović, N. (2009) Application of Fractional Factorial Design of Experiments to Live Attenuated Measles Vaccine Potency Assay Robustness Testing. U: Biopharmaceutical Emerging Best Practices Association (BEBPA)'s Annual Bioassay Conference.
@article{article, year = {2009}, keywords = {Potency assay validation, Measles vaccine, Design of experiments, Robustness}, title = {Application of Fractional Factorial Design of Experiments to Live Attenuated Measles Vaccine Potency Assay Robustness Testing}, keyword = {Potency assay validation, Measles vaccine, Design of experiments, Robustness}, publisherplace = {Rim, Italija} }