کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
10970217 1103037 2010 6 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Robustness testing of live attenuated rubella vaccine potency assay using fractional factorial design of experiments
موضوعات مرتبط
علوم زیستی و بیوفناوری ایمنی شناسی و میکروب شناسی ایمونولوژی
پیش نمایش صفحه اول مقاله
Robustness testing of live attenuated rubella vaccine potency assay using fractional factorial design of experiments
چکیده انگلیسی
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.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Vaccine - Volume 28, Issue 33, 26 July 2010, Pages 5497-5502
نویسندگان
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