The application of viral vectors in gene therapy is rapidly developing and the therapeutic results are highly promising. Actively and passively integrating (viral) vectors may fail to deliver, or trigger severe side effects by undirected or unintended integration into the genome of the target cell. Studies aiming to define and improve the efficiency and safety of the vectors should be conducted, according to regulatory recommendations, ahead of and during a clinical trial.
GeneWerk delivers a full service tailored to the needs of every client, from receiving samples to report delivery, including sample QC, library preparation, next generation sequencing, bioinformatics analysis and reporting.
We provide ISA with both PCR-based and non-PCR based approaches to analyse the vector and genomic junction sequences. After sequencing and bioinformatics analysis, the vector integration position and integration site frequency are the key deliverables for your vector safety assessment projects.
Our two decades of expertise in vector safety assessment, vector integration profiling, and clonality assessment in pre-and clinical gene/cell therapy clinical studies, as well as GCP/GCLP compliant services, enable us to support our clients in successful gene therapy programmes, CAR-T drug approval and market authorisation.