Integration Studies
When a plasmid construct is selected for clinical development of a genetic vaccine, the FDA may require that a study be conducted to confirm that plasmid DNA integration is either absent or at an insignificant level. A key factor in this determination is the limit of detection of the assay used. MDS offers Q-PCR integration assay has the capability to measure down to 5 copies of plasmid DNA per µg of genomic DNA. Due to this sensitivity, and the specificity of an assay that utilizes primers and a probe designed specifically for your plasmid, Q-PCR is ideally suited to integration studies.
The Assays Include:
- Receiving tissue(s) from the site of injection
- Separating high molecular weight genomic DNA from low molecular weight extra-chromosomal plasmid DNA
- Purify the high molecular weight DNA
- Designed the primers and a probe specific for client's gene therapy product
- Analyze the purified DNA on a custom real-time PCR assay
- Provide a comprehensive integration report
- Purify the high molecular weight DNA
- Analyze the purified DNA on a custom real-time PCR assay that utilizes the primers and a probe designed for your specific gene therapy product
- Provide a comprehensive integration report