Biodistribution studies are necessary to provide pre-clinical safety evaluation of novel gene therapy technologies and to address regulatory concerns. BioReliance designs biodistribution studies to investigate the integration or expression of the gene therapy viral vector construct into the germ line, the persistence of the vector in target tissues, and the dissemination of the vector into non-target tissues.
These assays can address:
- Viral vaccine efficacy
- Viral clearance
- Detection of virus in tissues
By combining the capabilities of our state-of-the-art animal facility and experienced staff, we can undertake a complete biodistribution study from design through completion.
We ensure that critical assay steps, such as nucleic acid extraction from tissues, are conducted under the most stringent conditions so that samples are optimized for highly sensitive molecular assays. Biodistribution studies are performed in GLP and GMP compliant facilities and meet full regulatory requirements.
Contact us for more information on how our biodistribution studies can meet your project needs.
What assay is used for Biodistribution studies?
Quantitative PCR (Q-PCR) is the method of choice for the detection and quantification of specified gene sequences in biodistribution or tissue dissemination studies. BioReliance is a world leader in the development and application of Q-PCR methods for assaying gene therapy biodistribution.
Quantitative PCR offers a highly sensitive, analytical method for determining whether nucleic acid (DNA or RNA) target is present in tissues. Extracted DNA is assayed directly, while RNA is reverse transcribed into cDNA. Q-PCR also can be used for determining the quantities of steady-state expressed mRNA.
For gene therapy studies (animal models), BioReliance offers Q-PCR assays to asses the viral copy number in both target and non-target tissues.
A biodistribution study also requires multiple controls including normalization for template (GAPDH), confirmation of reagent contamination, and verification of inhibitors. These steps ensure the sensitivity and reproducibility of the study.
Contact the BioReliance research team for more information on our biodistribution assay services.