Lentiviral Vector Characterization With Digital PCR For Genome Titer, VCN, And RCL Detection

By Miroslav Vraneš, Anne Schieren, Philipp Rink, Corinna Hochstein, Jonathan Thorn, Mario Quinto, Julius Albers, Domenica Martorana, Andreas Hecker, Ha minh Tri Pham, Anida Mesihovic Karamitsos, and Francesca Di Pasquale

Accurate characterization of lentiviral vectors is critical to advancing safe and effective cell and gene therapies. Explore how digital PCR streamlines the quantification of key quality attributes, including viral genome titer, vector copy number (VCN), and replication-competent lentivirus (RCL) detection. By eliminating the need for standard curves, digital PCR enables absolute quantification with high precision, strong tolerance to inhibitors, and consistent reproducibility across samples. The workflow demonstrates how duplex and triplex assays can be combined with genomic reference targets to deliver reliable VCN measurements, even across varying fluorophores and copy numbers. Robust RCL detection is also highlighted, showing sensitive performance across a wide dynamic range and in the presence of high background genomic DNA. The workflow also supports standardized, high-throughput lentiviral QC testing using wet-lab validated assays for genome titer determination, VCN analysis, and RCL detection. Together, these insights illustrate a practical, scalable approach to lentiviral vector analytics that supports regulatory expectations, process optimization, and consistent product quality.

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