Integration Site Analysis for Long-Term Safety Monitoring of Cell and Gene Therapy Products
TECH NOTE
Integration Site Analysis for Long-Term Safety Monitoring of Cell and Gene Therapy Products
As the dominant viral delivery vector for approved cell therapies, lentivirus requires integration site analysis (ISA) to assess the risk of off-target insertional mutagenesis. Measuring these genomic insertions with the right analytically validated assay and a robust bioinformatics workflow is essential for patient safety in pre-clinical and clinical trials. Here we compare ISA data from industry standard methods to help you find the best path forward for your lentiviral-based therapy.
What You'll Learn
- Performance characteristics of several NGS-based methods for integration site analysis
- Critical bioinformatic steps to generate meaningful data
- Experimental results characterized by false positive integration sites, on-target rate, and unique molecular identifier (UMI) diversity
