Vector Copy Number (VCN) Quantification Using Direct Cell Lysis And QIAcuity Digital PCR

By Anne Schieren, Philipp Rink, Anida Mesihovic Karamitsos, and Miroslav Vraneš

Accurate vector copy number (VCN) measurement is a critical quality attribute in gene‑modified cell therapies, yet traditional workflows can slow decision‑making with time‑consuming DNA extraction steps. Explore a streamlined approach that replaces conventional genomic DNA isolation with direct cell lysis combined with digital PCR. The workflow enables precise, reproducible VCN quantification across a wide range of cell inputs using both fresh and frozen samples, while significantly reducing hands‑on time. Results demonstrate strong linearity, low variability, and close agreement with expected integration levels across broad sample input ranges. The approach also supports multiplexed assays that simultaneously quantify lentiviral targets and reference genes in a single reaction, helping streamline QC and manufacturing workflows for CAR-T and other gene-modified cell therapies. For teams developing or manufacturing CAR‑T and other gene‑modified cell therapies, this method offers a practical path to faster analytics without compromising accuracy.

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