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Immunohistochemistry (IHC)
Specialty Pathology
Tissue cross-reactivity (TCR) studies
Tissue cross reactivity (TCR) is used to identify possible cross reactivity of novel biologicals with the primary aim of reducing the risk associated with first-in-human (FIH) testing. The assessment of potential cross reactivity involves the screening of and using of immunohistochemical staining techniques on frozen tissues.
TCR assessments are performed in accordance with the FDA Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use (1997) and the EMA ICH S6 (R1) Preclinical Safety Evaluation of Biotechnology Derived Pharmaceuticals (2011).
In the assessment, three donors of each tissue are screened for possible “off-target” binding. The results from these studies can also be used to compare staining patterns between human and research model tissues, providing additional justification for the choice of models used to generate other preclinical safety data.
About our nonclinical animal research models: We provide the utmost care for our research animals and actively pursue advances in animal welfare. As well as ensuring the highest scientific, ethical and regulatory standards, selection of appropriate animal research models for development research is critical to developing safe and effective treatments, devices and products that protect and save lives. Just as we have ethical committee oversight for human trials, we have ethical committees overseeing all aspects of our global animal care and use programs. All of our core, nonclinical facilities are accredited by AAALAC.Learn more about our commitment to replacing, reusing and refining nonclinical research models.