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

Abstract

This paper describes the salient points in establishing robustness of the cell-based potency assay, with reference to phase-specific qualification. 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. 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. The methodology was qualified and was robust with regard to assay parameters tested.