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Pregled bibliografske jedinice broj: 461644

Robustness Testing of Live Attenuated Rubella Vaccine Potency Assay using Fractional Factorial Design of Experiments

Kutle, Leonida; Pavlović, Nediljko; Dorotić, Marko; Zadro, Ivana; Kapustić, Marijana; Halassy, Beata
Robustness Testing of Live Attenuated Rubella Vaccine Potency Assay using Fractional Factorial Design of Experiments // Vaccine, 28 (2010), 33; 5497-5502 doi:10.1016/j.vaccine.2010.04.111 (međunarodna recenzija, članak, znanstveni)

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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

Izvornik
Vaccine (0264-410X) 28 (2010), 33; 5497-5502

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
pPotency 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. To revise the standard operating conditions and enhance the flexibility of the assay performance, the robustness testing of the rubella vaccine potency assay was performed. 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) with resolution IV (2IV(7-3)). The robustness testing through DoE showed that the rubella vaccine potency assay is a robust assay. Critical operating conditions can be identified by 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

Projekti:
MZOS-021-0212432-2033 - Imunogeničnost komponenti kompleksnih antigena (Halassy, Beata, MZOS ) ( CroRIS)

Ustanove:
Imunološki zavod d.d.

Profili:

Avatar Url Beata Halassy (autor)

Avatar Url Marijana Kapustić (autor)

Avatar Url Leonida Kutle (autor)

Avatar Url Nediljko Pavlović (autor)

Poveznice na cjeloviti tekst rada:

doi www.sciencedirect.com www.sciencedirect.com

Citiraj ovu publikaciju:

Kutle, Leonida; Pavlović, Nediljko; Dorotić, Marko; Zadro, Ivana; Kapustić, Marijana; Halassy, Beata
Robustness Testing of Live Attenuated Rubella Vaccine Potency Assay using Fractional Factorial Design of Experiments // Vaccine, 28 (2010), 33; 5497-5502 doi:10.1016/j.vaccine.2010.04.111 (međunarodna recenzija, članak, znanstveni)
Kutle, L., Pavlović, N., Dorotić, M., Zadro, I., Kapustić, M. & Halassy, B. (2010) Robustness Testing of Live Attenuated Rubella Vaccine Potency Assay using Fractional Factorial Design of Experiments. Vaccine, 28 (33), 5497-5502 doi:10.1016/j.vaccine.2010.04.111.
@article{article, author = {Kutle, Leonida and Pavlovi\'{c}, Nediljko and Doroti\'{c}, Marko and Zadro, Ivana and Kapusti\'{c}, Marijana and Halassy, Beata}, year = {2010}, pages = {5497-5502}, DOI = {10.1016/j.vaccine.2010.04.111}, keywords = {pPotency assay validation, rubella vaccine, design of experiments, robustness}, journal = {Vaccine}, doi = {10.1016/j.vaccine.2010.04.111}, volume = {28}, number = {33}, issn = {0264-410X}, title = {Robustness Testing of Live Attenuated Rubella Vaccine Potency Assay using Fractional Factorial Design of Experiments}, keyword = {pPotency assay validation, rubella vaccine, design of experiments, robustness} }
@article{article, author = {Kutle, Leonida and Pavlovi\'{c}, Nediljko and Doroti\'{c}, Marko and Zadro, Ivana and Kapusti\'{c}, Marijana and Halassy, Beata}, year = {2010}, pages = {5497-5502}, DOI = {10.1016/j.vaccine.2010.04.111}, keywords = {pPotency assay validation, rubella vaccine, design of experiments, robustness}, journal = {Vaccine}, doi = {10.1016/j.vaccine.2010.04.111}, volume = {28}, number = {33}, issn = {0264-410X}, title = {Robustness Testing of Live Attenuated Rubella Vaccine Potency Assay using Fractional Factorial Design of Experiments}, keyword = {pPotency assay validation, rubella vaccine, design of experiments, robustness} }

Časopis indeksira:


  • Current Contents Connect (CCC)
  • Web of Science Core Collection (WoSCC)
    • Science Citation Index Expanded (SCI-EXP)
    • SCI-EXP, SSCI i/ili A&HCI
  • Scopus
  • MEDLINE

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