FDA Policy

In 1997, the Center for Biologics Evaluation and Research (a division of the Food and Drug Administration and the Department of Health and Human Services) published recommendations for the approval of monoclonal therapeutic antibody products. Non-target specific binding to human tissue may have serious consequences when pharmacologically active antibodies (Ab) are used for treatment of disease. Thus, cross-reactivity studies of therapeutic Ab candidates are conducted prior to Phase I clinical trials to search for cross-reactivity or non-target tissue binding.

Testing for Antibody Cross-Reactivity

Antibody cross-reactivity is tested by immunochistochemical (IHC) staining using a set of snap-frozen normal adult human tissues. High-quality post-mortem normal human tissues procured within 3 – 12 hours PMI (post-mortem interval) are required to conduct effective antibody cross-reactivity study. Carefully selected frozen and FFPE normal human tissues are available to our clients for IHC studies. Cureline provides normal human tissues procured under the same collection protocols for antibody cross-reactivity studies to leading service providers in the USA and worldwide.

List of available normal human tissues could be downloaded here:  Normal Human Tissue Panel for antibody cross-reactivity studies.  Additional tissue types could be obtained upon request.