Genome Integrity Analysis Of Adeno-Associated Viruses (AAVs)

By Marcia Santos, Fang Wang, Jane Luo, and Sahana Mollah

In a world where drug development pipelines are growing exponentially, analytical scientists are looking for faster and innovative ways to remove bottlenecks without compromising the accuracy and precision of the analyses. This work demonstrates it is possible to evaluate the genome integrity and purity of adeno-associated viruses (AAVs) irrespective of their serotype in a high-throughput format by combining a chemistry kit with a multi-capillary electrophoresis system. Our results revealed that this assay is sensitive to lot-to-lot variations of full AAV8 samples, without interference from sample matrices. This work also demonstrates excellent inter-capillary reproducibility with %RSD values better than 0.2% for migration time (MT) and 1.6 % for corrected peak area (CPA) for the 8 markers in the ssRNA ladder standard.