Citoxlab – Your one-stop CRO for vaccine development
Biodistribution studies are a pivotal requirement during the preclinical development of gene therapy vectors. Such studies are designed to investigate the distribution (integration, expression, persistence and dissemination) of viral, plasmid or other DNA sequences to target or non-target tissues in clinically-relevant animals, and it is possible to evaluate the risk of vector dissemination in parallel. The choice of tissues in a biodistribution study depends on the nature of the tested product, the formulation, the dose-level and the route of administration. These studies are conducted under GLP conditions. Real-time quantitative PCR (or RT-qPCR) offers a highly sensitive method for determining whether a tissue was exposed to the vector.
Biodistribution studies are performed at Citoxlab by highly qualified, experienced scientific and technical staff using a whole range of validated tests and equipment (from in vivo through to qPCR data analysis and interpretation). We have extensive expertise in DNA/RNA extraction from all sample types.
Citoxlab can be a valuable partner, helping you set up the necessary validation studies prior to biodistribution studies. Citoxlab provides a complete GLP-compliant biodistribution study solution with optimized performance of the assays ensuring reproducibility, sensitivity, and accuracy.
- Upon request
- Fluids (CSF, urine, milk)
Experience with a wide variety of compounds
Advanced electronic data support
- SDS software
- SYBR Green
- Detection limit 5 copies
- Quantification limit 10 copies
- Linearity range and detection limit
- Inhibition monitoring
- Specificity and reproducibility
- Matrix effect
- Extraction yields