Immunotoxic response can originate from direct toxicity of the pharmaceutical to components of the immune system. Direct immunotoxicity may result in either immunosuppression or immunostimulation. Alternatively, the immune system may react to chemicals in an antigen-specific way. Therefore, immunotoxicology is an important aspect of the safety evaluation of drugs and chemicals. Despite the remarkable success of rodent-based models in determining immunotoxicity, there are limitations in extrapolating the risk posed to humans. Immunotoxicological data resources derived from studies using human primary leukocytes can facilitate rational decision making for drug development.
Skimune® Immunotoxicity Testing Platform
Amerigo Scientific offers Skimune® Immunotoxicity Testing, which can be used as a "first in human study" for safety and efficacy testing of drugs, chemicals, or cosmetics. This in vitro test could serve as an alternative to animal models.
Based on Skimune® Immunotoxicity Testing platform, it is possible to predict the adverse immune response triggered by the tested compound, demonstrating whether the compound has the potential to activate the human immune system by analyzing dendritic cells/T cells activation, cytokine release and histopathology associated with allergy, hypersensitivity, or sensitization.
Benefits
- Rapid identification of adverse immune responses that cannot be detected in animal models
- More sensitive and predictive of outcome compared to the results of animal models
- Human cell- and tissue-based testing that incorporates multiple key events of the adverse outcome pathway (AOP)
- A wide range of compounds that can be tested, including small molecules, monoclonal antibodies, cell therapies, raw materials, end products, and more
- A comprehensive testing incorporating T cell proliferative response, cytokine response, and skin explant histopathology
- High predictability (over 200 compounds tested) with 80-90% accuracy
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