A Fit-for-Purpose Approach to Monitor Circulating Dendritic Cell Subpopulations for Clinical Investigation

Dendritic cells (DC) are a heterogeneous population of antigen presenting cells involved in the capture, processing and surface presentation of antigens to T-cells. Their immune functions serve to connect innate and adaptive immune responses. In human peripheral blood, the two main subpopulations of dendritic cells, myeloid and the plasmacytoid, are of interest as biomarkers for the development of new therapies and clinical indications. A fit-for-purpose approach was applied to the validation of a two related flow cytometric method designed to evaluate both myeloid and the plasmacytoid dendritic cell populations. The iterative approach allowed us to tailor the assays for and the validation for the intended use of the data within the clinical trial. This presentation describes the rationale for the panel design and the technical validation approach.