Working Toward an Adenoviral Vector Testing Standard

As the development of adenoviral vectors for gene delivery applications broadens and moves forward, the possibility of approved therapeutic products draws nearer. However, regulatory approval of new classes of drugs–including gene therapy–requires a good safety profile of the product, composed of product-specific data as well as collective data from products that share common elements in the platform technology. In the case of adenovirus, the analysis of safety and efficacy across the product class currently relies on data generated by nonstandardized methods and comparability between quantities such as viral particle, which are relatively imprecise (see below).