Streamlined dPCR workflow for lentiviral characterization and QC of cell and gene therapies

Lentiviral vectors form the basis of many ex vivo gene-modified cell therapies, including CAR-T and other engineered T cell products. As manufacturing grows, analytical tools must keep up with changing demands for safety, potency, and consistency. Digital PCR has become a reliable, absolute method for measuring key quality attributes of lentiviral products, such as vector genome titer, integrated vector copy number, and the absence of replication-competent lentivirus. This article outlines a streamlined digital PCR workflow that uses CGT-specific assays and a direct lysis protocol to enhance efficiency and reproducibility while lowering operator burden. Application datasets demonstrate the performance of this integrated workflow across various lentiviral matrices. Collectively, these approaches emphasize the increasing importance of digital PCR in supporting QC strategies aligned with regulatory expectations in CGT manufacturing.