Recombinant adeno-associated virus (rAAV) vectors are becoming an increasingly popular vector system for gene delivery, thanks to their customizability and superior biosafety.
Despite this excellent biosafety, comprehensive characterization of process- and product-related impurities in rAAV drug products has to be carried out to ensure patient safety and meet regulatory requirements.
GeneWerk combines powerful NGS-based AAV genome sequencing and dedicated bioinformatics pipelines to identify and quantify residual DNA impurities and analyze rAAV 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.
AAVSEQ 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, AAVSEQ provides information about vector identity and integrity.
Compared to qPCR, AAVSEQ 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.
Read our latest press releases and announcements below.
GeneWerk will expand capabilities to meet rapidly growing demand for cell and gene therapy...