Vector characterization and validation 2020

The right analytical toolbox is key to moving your pipeline forward

Cell & Gene Therapy Insights 2020; 6(7), 1029–1033

10.18609/cgti.2020.113

Published: 25 August 2020
Commentary
Andrew Espejo

The advancements of vector analytics within the field of viral gene therapy have evolved past simple qPCR testing for viral genomes. These analytical techniques have become the backbone of any process optimization, and are critical in making the decision to move forward with any optimized manufacturing steps. With many AAV gene products entering early and late stage clinical trials, having the right process to ensure consistency, quality, and efficacy is critical now more than ever – and the right analytical techniques can guide you towards the right decisions. This article will describe the most advanced analytical tests available for in-process optimization, and will explore the best time to use them. As well as having the right techniques in place, exploring different avenues within other fields of science is another approach which can push analytical characterization in viral vector testing towards new frontiers.