Standardizing CAR‑T quality control: dPCR‑based approaches for reliable VCN and RCL testing

As CAR‑T therapies move toward larger‑scale and GMP manufacturing, robust analytical strategies are increasingly critical for ensuring product safety, consistency, and regulatory readiness. This article presents digital PCR‑based approaches for vector copy number and replication‑competent lentivirus testing, evaluated across small‑scale manual and automated CAR‑T manufacturing platforms, with key findings regarding plasmid DNA interference and practical recommendations for assay design.

What you will learn

01

Why dPCR is preferred over qPCR for VCN and RCL testing, using Poisson statistics across tens of thousands of partitions to remove standard-curve variability

02

How residual plasmid DNA from research-grade lentiviral vectors can generate false-positive VSV-G signal, and why co-detection of AmpR resolves this interference

03

How VCN and RCL assay performance compares across CliniMACS Prodigy, G-Rex, and Cytiva Xuri manufacturing platforms at MOI 5

Key interests

CAR-T manufacturing Digital PCR Vector copy number RCL testing Lentiviral vectors Quality control GMP manufacturing

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