Biotechnology Services
Gene Therapy Products |
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Gene therapy vector biodistribution
FDA and EMEA require examination of the biodistribution, persistence and expression of gene therapy vectors during preclinical safety studies. At Covance, we have accumulated extensive experience of applying PCR to examination of gene therapy vector fate in tissue samples, biological fluids and excretion products. We can perform all aspects of a gene therapy preclinical safety study, including in vivo safety assessment, necropsy, histology, DNA/RNA extraction and PCR or quantitative PCR. We have experience of working with a range of gene therapy vectors including both viral and plasmid DNA vectors and, as of end-2001, have conducted biodistribution studies for more than 20 clients. Features of our service include:
- Expert scientific and regulatory advice
- Involvement in Eurogenethy, European regulatory meetings for gene therapy safety
- Involvement in Williamsburg Foundation adenovirus RCA vector standard project
- Dedicated sample extraction suite and toxicology facilities
- Stringent operating practices to avoid cross-contamination
- Dedicated multi-lab PCR facilities
- Structured sample analysis — groups/timepoints
- Analysis of multiple sample replicates to increase PCR sampling
- Inclusion of sample-specific spiked controls to monitor for sample-derived inhibition
- Gene expression studies using ABI Prism® 7700
- Tabulated data in audited report for submission to regulatory authorities
- Full quantitative PCR capability.
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