Citoxlab – Adding the latest technologies to your research in gene and cell therapy products
Gene and cell therapy products are at the forefront of modern medicine, and Citoxlab has helped its partners in the preclinical development of many viral, plasmid or cell-based drug products.
For each product, detailed biodistribution data are required by regulatory authorities. We combine our extensive experience in toxicology with our expertise in genomics, to offer you advice and robust biodistribution studies which meet the expectations of current authority guidelines. We can use diverse matrices from the whole panel of animal models and development states to investigate a wide range of compounds (vaccines, cells, plasmids, viruses, etc.).
With a suitably qualified detection system (qPCR) and genomics-specific necropsy procedures, we are able to detect as little as five copies of gene or cell DNA in any tissue or fluid in any species. Together with our expertise in other areas, such reprotox, we are able to offer complete investigations covering integration, expression, persistence and shedding.
qPCR validation studies include :
- TaqMan or SYBR green
- Linearity of dynamic range
- Detection limit (approx. 5 copies)
- Inhibition monitoring
- Specificity, reproducibility
- Matrix effect
- Extraction yields