Route of Administration Mimicry
To accurately simulate clinical scenarios, our company designs biodistribution studies that mimic the intended routes of administration in humans. Whether intravenous, intramuscular, subcutaneous, or other routes, these studies provide crucial insights into how materials or therapies disperse throughout the body and target specific tissues or organs.
Quantification of Material Levels
Utilizing state-of-the-art analytical methods, our company quantifies levels of transgenes, proteins, drugs, or gene-modified cells in target and non-target tissues. This quantification not only confirms successful transduction of target tissues but also assesses potential off-target effects, guiding safety evaluations and therapeutic optimization.
Immunocompromised Models and Specialized Studies
For studies requiring immunosuppression regimes or specialized models, our company offers expertise in designing and executing complex biodistribution protocols. This includes assessing biodistribution in immunocompromised animals or evaluating specific cellular or tissue responses to gene therapies or materials.
Supporting First-in-Human Trials
One of the primary goals of biodistribution studies is to generate critical data supporting first-in-human (FIH) trials. Our company's meticulous approach in assessing tissue-specific detrimental effects, alongside traditional pharmacokinetic (PK) assessments and safety endpoints like clinical pathology and histopathology, reinforces the safety and efficacy profiles of emerging materials and therapies.
