Biopharmaceuticals tissue cross-reactivity testing

Tissue cross-reactivity studies are required by FDA for monoclonal antibody products to determine if the product binds to target and/or nontarget tissues. They are also performed for nonmonoclonal biopharmaceuticals if warranted. For example, ARANESP was tested in a human tissue panel ex vivo to determine if it bound to nontarget tissues or cross-reacted with related cytokine receptors. These studies are also used to explore known or potential clinical adverse safety events (i.e., mechanism of toxicity). For example, one patient in a Raptiva study developed unilateral hearing loss. This finding was further evaluated by cross-reactivity studies with human optic chiasm, acoustic nerve, and inner ear tissues. 

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