Recombinant adeno-associated virus (rAAV) is one of the most promising viral vectors in the field of gene therapy for genetic disorders, as demonstrated by the increasing number of clinical trials and promising results.
Rapid, at-line, accurate methods for the quantitation of AAV virus particles are essential for bioprocessing in gene therapy.
Capsid titer is commonly measured by ELISA, while empty vs. full capsid titer differentiation and ratio are obtained with analytical ultracentrifuge (AUC), and viral genome titer is measured increasingly by ddPCR. Current methods are time consuming and labor intensive, and hence are not practical for at-line, rapid measurement of viral titer to monitor development of bioprocess and manufacturing. In this article, we report the development of a rapid, high-throughput capsid assay for AAV2 on ForteBio’s Octet platform that demonstrates excellent precision, reliability in comparison to ELISA and ddPCR that can be applied as a generic assay method for viral titer at-line in a bioprocess setting.