Immunotoxicity Testing pp 303-321 | Cite as
Flow Cytometry in Preclinical Drug Development
Abstract
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.
Key words
Preclinical drug development Flow cytometry Cross-reactivity Monoclonal antibody Immunophenotyping Receptor dynamicsNotes
Acknowledgments
The author would like to acknowledge Charles River Laboratories for providing the opportunity to build on a long term interest in flow cytometry through supported development of a laboratory and experimental assays that clearly enhance preclinical safety assessment. The author would like to thank Dr. Keith Reimann for development and optimization of the receptor occupancy assay, and for his advice and encouragement in general flow cytometry analyses. The author would also like to acknowledge Dr. Rafael Ponce for editorial review and content advice, and Dr. Stephanie Fraser for technical and editorial contributions to this work.
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