Vector Integration Site Detection

Vector Integration Site Detection

Genomic integration of viral and non-viral vectors is a key safety consideration in cell and gene therapy product development. The random nature of integration can cause insertional mutagenesis, gene silencing or activation, and even clonal proliferation risks. GeneRulor has developed a high-sensitivity, high-throughput integration site detection technology platform targeting multiple vector types, including lentivirus, retrovirus, transposon systems, AAV, and plasmids. LM-PCR (ligation-mediated PCR) enables genome-wide capture and precise mapping of integration sites for lentiviral and transposon vectors, identifying integration hotspots, assessing integration site distribution preferences, and analyzing potential impacts on critical genes (e.g., oncogenes, tumor suppressor genes) using gene annotation databases. Liquid-phase hybridization capture technology targets AAV and plasmid vector integration events — through vector-specific probe enrichment combined with deep sequencing — enabling sensitive detection of low-frequency integration events to meet regulatory assessment requirements. For in vivo applications, we provide In vivo CAR-T integration site detection services to track clonal dynamics of CAR-T cells in patients and evaluate long-term safety. All detection results include genomic coordinates of integration sites, copy number, gene functional annotation, safety risk assessment reports, and optional Sanger sequencing verification. The platform covers the full workflow from vector design optimization and process development to lot release testing, providing FDA/NMPA-compliant integration site safety data for lentiviral CAR-T, γ-retroviral TCR-T, transposon-engineered cells, AAV gene therapy, and other products.