Accelevir offers a library of pre-validated AAV assays and lentiviral vector assays to accelerate timelines for gene therapy regulatory submissions. These assays are optimized for high sensitivity, reproducibility, and cross-species compatibility to meet FDA, EMA, and PMDA requirements.
Capabilities:
- qPCR/dPCR assays for AAV vector genome detection and lentiviral copy number quantification.
- GLP-ready workflows for biodistribution, shedding, and residual DNA testing.
- Assays for multiple AAV serotypes and common LV backbones.
- Manufacturing QC and in vivo monitoring integration.
Applications:
- AAV biodistribution studies for IND filings.
- Lentiviral vector safety testing.
- Residual plasmid DNA detection for release testing.
- Persistence tracking of transduced cells post-infusion.