AGI supports the rapidly advancing field of gene and cell therapy with in vivo platforms specifically designed to meet the unique challenges of these modalities. Our programs evaluate a wide range of delivery technologies, including adeno-associated virus (AAV), lentiviral vectors, lipid nanoparticles (LNPs), and engineered cellular therapies, using longitudinal endpoints that align with regulatory expectations. We provide robust data on biodistribution, persistence, tissue tropism, transgene expression kinetics, and immune response, integrating molecular assays such as qPCR, RNA sequencing, and in situ hybridization with advanced in vivo imaging. Long-term monitoring capabilities allow us to characterize re-dosing paradigms, immune clearance, and safety liabilities over extended timeframes, while our immunotoxicology expertise enables comprehensive characterization of adaptive and innate immune responses to vectors or transgenes.

 

With GLP-compliant facilities and teams experienced in preparing IND-enabling packages, Alpha Genesis delivers high-quality, reproducible datasets that provide regulators and sponsors with confidence in translational readiness. Our integrated approach ensures that novel gene and cell therapies can advance efficiently from preclinical development into first-in-human trials with minimized risk, maximized scientific clarity, and stronger alignment with evolving global regulatory standards.