Research and Development Department, Institute of Immunology, Inc., Rockefellerova 10, HR-10000 Zagreb, Croatia.
Vaccine. 2010 Jul 26;28(33):5497-502. doi: 10.1016/j.vaccine.2010.04.111. Epub 2010 May 14.
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.
冻干减毒风疹活疫苗的效力检测是一种基于细胞培养的生物学检测方法。本研究的目的是在进行验证之前，对风疹疫苗效力检测进行稳健性测试。通过实验设计（DoE）的部分因子设计，确定了 7 个可能影响检测性能的实验室内操作条件，并研究了它们对总检测变异性的影响。通过 DoE 进行的稳健性测试表明，风疹疫苗效力检测是一种稳健的检测方法。通过 DoE 可以确定关键操作条件，这表明它是生物测定稳健性研究的一种合适方法。
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