Tissue cross-reactivity (TCR) studies are in vitro tissue-binding assays employing immunohistochemical techniques, conducted to characterize binding of monoclonal antibodies and related antibody-like products to antigenic determinants in tissues.
In vitro test with tissues.
Phase I: Optimization of the immunohistochemical staining (non-GLP).
Phase II: Preliminary staining of full human tissue panel (FDA and EMEA panels, non-GLP).
Phase III: In-process validation of immunohistochemical staining of full human tissue panes (FDA and EMEA panels, GLP) using three donors per tissue type.
Full report containing the description of all stainings observed in any tissue type and representative images of the microscopical findings.