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Immunotoxicology & Genetic Safety

AGI delivers advanced immunotoxicology and genetic safety services that enable the rigorous evaluation of candidate therapeutics before they advance into clinical development. Our in vivo and ex vivo platforms are designed to assess immune activation, cytokine release, immunogenicity, and genetic stability under both exploratory and GLP-regulated conditions. With extensive experience in vaccine development, gene and cell therapies, and biologics, our team provides critical data on immune system interactions, host response, and long-term safety profiles. We integrate state-of-the-art technologies, including multiplex cytokine panels, flow cytometry, and molecular assays, to generate comprehensive datasets that meet FDA, EMA, and global regulatory expectations.

 

Every study is executed with precision, ensuring not only compliance with rigorous oversight requirements but also meaningful translational insights to guide dosing strategies, product optimization, and patient risk assessment. By combining technical expertise with robust animal care and validated biosecurity protocols, AGI ensures the reproducibility and reliability of immunotoxicology outcomes. Our services support pharmaceutical sponsors, academic collaborators, and government agencies worldwide, helping to de-risk development programs and safeguard patients while advancing cutting-edge biomedical innovation.

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