Development of a Potency Assay for Human Dendritic Cells: IL-12p70 Production

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Abstract
The development of potency assays for characterization of cellular products used for human therapy throughout early-phase clinical trials is recommended by FDA. We present the results of the development of a standardized IL-12p70 production assay, which is applicable to small samples or large lots of dendritic cell (DC) vaccines generated under a variety of conditions. The assay measures the DC ability to secrete IL-12p70 and respond to helper T-cell signals (CD40L) with or without additional innate immunity signals. It then quantifies IL-12p70 using an immunobead multiplex platform. This 2-step functional assay provides a controlled, reproducible, robust, and cost-effective potency measure for human DC. It discriminates between DC matured in the presence of different cytokine cocktails and between DC obtained from normal donors and patients with human immunodeficiency virus-1 or cancer. It defines the stability of DC vaccines. It's application to DC assessments in several on-going early-phase clinical trials is expected to provide data defining the assay value in predicting in vivo efficacy of DC-based vaccines.