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

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.

pPotency assay validation ; rubella vaccine ; design of experiments ; robustness

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