title: Robustness testing of live attenuated rubella vaccine potency assay using fractional factorial design of experiments.
abstract: 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.
authors.affiliation: Research and Development Department, Institute of Immunology, Inc., Rockefellerova 10, HR-10000 Zagreb, Croatia.
authors.forename: Leonida
authors.initials: L
authors.lastname: Kutle
authors.forename: Nediljko
authors.initials: N
authors.lastname: Pavlović
authors.forename: Marko
authors.initials: M
authors.lastname: Dorotić
authors.forename: Ivana
authors.initials: I
authors.lastname: Zadro
authors.forename: Marijana
authors.initials: M
authors.lastname: Kapustić
authors.forename: Beata
authors.initials: B
authors.lastname: Halassy
mesh_terms: D000818:Animals; D001681:Biological Assay / Q000379:methods*; D002460:Cell Line; D004353:Drug Evaluation, Preclinical / Q000379:methods; D006801:Humans; D012411:Rubella Vaccine / Q000276:immunology*; D014613:Vaccines, Attenuated / Q000276:immunology
chemical_list: D012411:Rubella Vaccine; D014613:Vaccines, Attenuated