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Gammaretroviral and lentiviral vectors are powerful tools for cell and gene therapy. Comprehensive characterization of process- and product-related impurities in retroviral drug products contributes to the safety of in vivo and ex vivo therapies.
GeneWerk combines powerful NGS-based retroviral genome sequencing and dedicated bioinformatics pipelines to identify and quantify residual DNA impurities and analyze retroviral genome identity and integrity. Furthermore, our customized bioinformatics analysis gives clients more control at every stage, from vector design to vector CMC procedure optimization, leading to improved vector batch control.
LENTISEQ provides a more comprehensive picture of vector quality and safety than standard qPCR-based impurity detection since it overcomes the need for a primer binding site. Apart from the origin and quantity of impurities, LENTISEQ provides information about vector identity and integrity.
Compared to qPCR, LENTISEQ is around 8-10 times cheaper for more than three loci and provides comprehensive information, including origin, quantity, special characterization of producer cell-derived impurities, vector identity, and vector integrity.
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