Preclinical immunotoxicology studies are essential for evaluating the potential impact of drug candidates, chemicals, or biologics on the immune system before progression to first-in-human clinical trials. These studies help identify immune-related safety risks early, supporting informed decision-making and patient protection during clinical development.
Our preclinical immunotoxicology team brings together scientists with deep expertise across immunology, toxicology, and related disciplines. We design tailored assessment programs based on the unique characteristics of each compound, providing scientific guidance, regulatory support, and high-quality data to support the advancement of drug candidates into clinical trials.
To learn how our immunotoxicology and immunology services can support your drug development goals, contact us today.
With more than 30 years of experience in immunotoxicology research, we develop customized assessment strategies aligned with the therapeutic pharmacology and clinical intent of each compound. Our scientists support programs from early discovery through clinical development, evaluating a wide range of small and large molecules.
Our studies focus on identifying key immunotoxic effects, including immunosuppression, immune stimulation, hypersensitivity reactions, and autoimmune responses. Using a combination of in vitro assays and in vivo models, we generate comprehensive data to support compound selection and regulatory submissions worldwide.
Immunotoxicology assessments are conducted across multiple species and are supported by integrated bioanalysis and histopathological evaluation. These studies provide insight into:
Our bioanalytical and immunology experts work collaboratively to develop and validate analytical methods in compliance with the Food and Drug Administration, the International Council for Harmonisation, and Good Laboratory Practice requirements. Preclinical samples are analyzed using validated assays to ensure data accuracy and regulatory acceptance.
We deliver comprehensive immunotoxicity evaluations using advanced techniques such as flow cytometry, immunogenicity testing, receptor occupancy analysis, and cytokine profiling. Our assessments include immunophenotyping, biomarker evaluation, and functional immune assays to provide a detailed understanding of immune system interactions.
Key immunotoxicology evaluations include:
Our bioanalytical laboratories are equipped with advanced instrumentation to support precise and reproducible immune assessments. These technologies enable high-quality data generation across a broad range of immunological endpoints.
Key laboratory platforms include electrochemiluminescence sector imagers, multimode plate readers, multiplex immunoassay systems, automated microplate washers and dispensers, multi-laser flow cytometers, immune response analyzers, and magnetic particle processing systems.
By leveraging our extensive experience in preclinical immunotoxicology, we help sponsors make confident, data-driven decisions regarding the immune safety of their compounds. Our integrated approach supports safer drug development, from early discovery through regulatory approval.
If you have questions about our immunotoxicology studies or would like guidance tailored to your program, please reach out to our experts. We are here to support your development journey at every stage.