Researchers spotlight extracellular vesicles (EVs) as nonviral vectors for safer, more targeted gene and protein delivery while industry commentary highlights droplet digital PCR (ddPCR) as the gold standard for absolute nucleic acid quantification in cell and gene therapy workflows. EV-based platforms aim to reduce immunogenicity and insertional risks associated with viral vectors by leveraging natural vesicle trafficking for payload delivery. Complementing delivery advances, ddPCR’s partitioning and Poisson‑based readout enable rare‑variant detection and precise titration of gene edits or transgene levels without standard curves, supporting manufacturing release assays and sensitive monitoring of off‑target events. The combination of EV carriers with ddPCR analytics could streamline preclinical validation and QC for next‑generation gene therapies. Sponsors and CDMOs should evaluate EV scalability and ddPCR integration into GMP analytical packages; regulatory submissions will require robust controls for EV cargo heterogeneity and ddPCR assay validation. Sources: innovation spotlights and methodological reviews.
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