Analysis Of DNA Integrity And Stability Using Digital PCR

By Kevin Matthäi, Jonathan Thorn, Mario Quinto, Anne Schieren, Julius Albers, Philipp Rink, Aswinkumar Vijayananth, Blazej Kramarski, Celia Bielemeier, and Domenica Martorana, QIAGEN

Gene therapy is transforming the treatment of genetic disorders, with over 30 FDA-approved therapies and thousands more in development worldwide. At the core of many of these therapies are recombinant adeno-associated virus (AAV) vectors, which deliver therapeutic genes to target cells. However, the performance of these vectors and ultimately the safety and efficacy of the therapy depend heavily on genome integrity. Truncated or incomplete genomes can reduce vector potency, making accurate and reproducible integrity testing a critical requirement across development and manufacturing.

To meet this need, digital PCR (dPCR) offers a precise, multiplexable method for quantifying both total DNA and the proportion of physically intact genomes in AAV samples. The QIAcuity® dPCR System uses Poisson-based analysis to deliver accurate integrity scores across up to five targets in a single run, providing vital insights into fragmentation, packaging quality, and sample stability.

Explore the full application note to see how this method streamlines AAV integrity testing and boosts reproducibility across gene therapy workflows.