Characterization of gene therapy drug products to determine vector identity, quantify impurities, and assess replication competence, minimizes risk for patients in clinical trials and beyond. At GeneWerk, we provide the full spectrum of assays for vector quality control in line with current FDA and EMA regulatory guidelines.
Early understanding of vector quality attributes, right from pre-clinical development, will help reduce costs and accelerate timelines. Our end-to-end services for vector quality control link findings from different stages of development – from pre-clinical to clinical – to gain an early and comprehensive understanding of the drug product.
At GeneWerk, we combine powerful NGS-based techniques with streamlined bioinformatics analysis to provide a complete picture of vector quality and safety.
Our comprehensive service portfolio includes sample preparation, library preparation, next-generation sequencing, bioinformatics analysis and reporting.
Adeno-associated virus sequencing (AAVSEQ) is an NGS-based approach to identify and quantify residual nucleic acid impurities and analyze AAV genome identity and integrity in pre-clinical and clinical AAV preparations.
Lentivirus sequencing (LENTISEQ) is a similar NGS-based approach to identify and quantify residual nucleic acid impurities, including genome identity confirmation, in pre-clinical and clinical retroviral preparations.
Read our latest press releases and announcements below.
GeneWerk will expand capabilities to meet rapidly growing demand for cell and gene therapy...