AGI provides comprehensive dosing route optimization services to ensure therapeutic candidates are delivered, distributed, and expressed effectively in vivo. Our expertise spans all major administration routes, including intravenous, intramuscular, subcutaneous, oral, and intranasal, allowing sponsors to evaluate pharmacokinetics, biodistribution, immunogenicity, and expression patterns under clinically relevant conditions. By combining advanced imaging, biomarker profiling, and telemetry-based monitoring, we generate high-resolution data that informs both safety and efficacy assessments. Each program is tailored to sponsor objectives, from early exploratory studies to fully GLP-compliant regulatory submissions, with a focus on defining the most effective route of delivery for complex modalities such as vaccines, biologics, and gene and cell therapies.

 

Our integrated teams of veterinarians, surgeons, and pharmacologists ensure dosing procedures are executed with precision, reproducibility, and adherence to global regulatory expectations. Beyond technical execution, we emphasize translational relevance, designing studies that not only characterize product performance in primate models but also provide clear guidance for human clinical development. Through this combination of scientific rigor, regulatory alignment, and operational excellence, Alpha Genesis helps sponsors de-risk development pipelines, accelerate decision-making, and achieve reliable outcomes that support FDA, EMA, and international approval pathways.