Validation of the COSTIM bioassay for dendritic cell potency.

Dendritic cells (DCs) are increasingly prepared in vitro for use in clinical trials of human disease. Their utility in experimental immunotherapy has driven significant advances in the manufacture of these cells. Thus it has become imperative that, in concert with other quality control measures, a potency test be utilized for the GMP/GLP lot-release of DC products for preclinical and clinical studies.