Tissue cross reactivity (TCR) testing

Aim:

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.

Test system:

In vitro test with tissues.

Design:

Phase I: Optimization of the immunohistochemical staining (non-GLP).

Selection of suitable positive and negative control tissues/cells
Sptimization of the staining procedure
Determination of the concentration range of test antibody for Phase II and III
Selection of positive control antibody

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.

Reporting, outcome:

Full report containing the description of all stainings observed in any tissue type and representative images of the microscopical findings.