Flow Cytometry in Preclinical Drug Development

Flow cytometry has many applications in clinical medicine allowing rapid and highly specific characterization of cells in solution (e.g., peripheral blood) or from dissociated tissues. The data generated from these analyses may be used to diagnose and monitor progression of disease as well as aid in prognostication of selected pathologic processes. In recent years, flow cytometric techniques have established a foothold in preclinical drug development providing an ability to identify and characterize both cell morphology and function, as well as to more clearly assign observed alterations in one or more cell attributes as intended or unexpected effects of new biopharmaceutical entities. The inclusion of flow cytometric evaluation assays (some described in this chapter) during preclinical drug development has increased and enhanced the detail of data generated to support the safety and efficacy of new biopharmaceuticals. Flow cytometry analyses used in preclinical drug development that are described in this chapter include immunophenotyping, peripheral blood cross-reactivity, binding activity and stability and cell receptor dynamics.