AGI provides end-to-end immunopharmacology and immunotoxicology capabilities designed to characterize how investigational products interact with the immune system across a broad spectrum of applications. Our studies incorporate detailed immune profiling, including cytokine release panels, immune cell activation assays, vaccine adjuvanticity testing, and longitudinal monitoring of immune modulation. Using a suite of validated technologies, flow cytometry, ELISpot, multiplex bead-based assays, and next-generation sequencing, we deliver high-resolution insights into both innate and adaptive immune responses. These datasets allow sponsors to assess potential immunogenicity risks, evaluate dose-dependent immune modulation, and identify mechanisms of action with regulatory precision.

 

Our programs are fully aligned with FDA, EMA, and ICH guidance, ensuring that sponsors can meet immunogenicity assessment requirements for biologics, vaccines, and gene or cell therapies. With GLP-compliant infrastructure, experienced immunologists, and the ability to tailor study design to novel modalities, AGI delivers reproducible, regulatory-grade results that de-risk development and provide confidence in immune safety profiles, while supporting the advancement of therapies with improved safety and efficacy.