Integration Studies

AltheaDx is currently one of the few companies offering a quantitative real-time PCR method to evaluate plasmid DNA vaccine integration into host cell genomic DNA.

When a plasmid construct is selected for clinical development, 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. AltheaDx's qPCR 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, qPCR is ideally suited to integration studies.

Our scientists will work closely with your research investigator to design a signature assay customized to your specific study needs. Once AltheaDx has received tissue from the site of injection, our scientists will:

• Separate high molecular weight genomic DNA from low molecular weight extrachromosomal plasmid DNA
• Purify the high molecular weight DNA
• Analyze the purified DNA with a custom real-time qPCR assay that utilizes the primers and a probe designed for your specific plasmid DNA product
• Conduct study in compliance with GLP if required
• Provide a comprehensive integration study report