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Aim: This paper describes the salient points in establishing robustness of the cell-based potency assay, with reference to phase-specific qualification. Materials &amp; methods: The methodology was qualified in a thaw for use format utilizing standard parameters. At a later stage, the assay was further developed, and concomitant with requalification the robustness was assessed by fractional factorial design of experiment, the center point data being used for qualification. Results: The methodology was qualified with a precision of 8.5% and mean bias of 3.6%. The robustness data generated a similar precision and accuracy/bias to the qualification data. Assay factors were optimized to be within the design space model of the design of experiment. Conclusion: The methodology was qualified and was robust with regard to assay parameters tested.

Design of experiment in assessing robustness and for qualification of a cell-based potency assay