AAV serotype associated impurities under a production platform
Adeno-associated viruses (AAVs) are among the most popular vectors for gene therapies due to its favorable tissue tropism and lack of pathogenicity. As recombinant AAVs are produced using living host cells some variability is involved in their manufacturing together with the presence of multiple contaminants such as empty capsids, immunogenic protein impurities and host cell DNA fragments.
Most of the AAV vector production to date has been performed at a small–medium scale using transfection-based production methods. In more advanced clinical trials or when moving to non-rare diseases, larger vector amounts are required. Viralgen is a CDMO that has developed a powerful and scalable platform for the production of AAV of diverse serotypes. Numerous batches have been already manufactured at 50, 250, 500 and 2000 liters in the past years, which have been used in several clinical trials around the world. This platform strategy has allowed us to generate a considerable amount of data, which results in an added value to try to understand the variability during the manufacturing processes, as well as the impurities associated with each serotype.