Title | IsoTag™AAV: an innovative, scalable & non-chromatographic method for streamlined AAV manufacturing |
Publication Type | Journal Article |
Year of Publication | 2022 |
Authors | Haley, J, Jones, JB, Petraki, S, Callander, M, Shrestha, S, Springfield, E, Adamson, L, Chilkoti, A, Dzuricky, MJ, Luginbuhl, KM |
Journal | Cell & Gene Therapy Insights |
Volume | 8 |
Issue | 10 |
Pagination | 1287-1300 |
Date Published | Nov-3-2022 |
Abstract | Demand for gene therapies capable of treating previously inaccessible targets has risen precipitously in the past decade. Adeno-associated viruses (AAVs) are the preferred vector for gene delivery because of their favorable safety profile and tissue tropism, but they have significant manufacturing challenges, with end-to-end yields as low as 10–30%. To combat these low yields, we developed IsoTag™AAV, a novel purification technology for AAV that is a departure from the chromatographic paradigm in downstream processing. This proprietary technology uses a self-scaffolding recombinant protein reagent that can improve manufacturing yields. It enables purification by cost-effective and scalable filtration processes and improves product quality with minimal optimization. Herein, we describe the development of IsoTag™AAV, provide a head-to-head comparison to industry-leading affinity chromatography (evaluation carried out through a joint research project with Capsida Biotherapeutics), and demonstrate how it can reduce cost of goods for a clinical AAV program by 25%. |
URL | https://insights.bio/cell-and-gene-therapy-insights/journal/article/2629/IsoTagAAV-an-innovative-scalable-non-chromatographic-method-for-streamlined-AAV-manufacturing |
DOI | 10.18609/cgti.2022.190 |