Adeno-associated virus (AAV) is an attractive gene delivery platform due to its safety, efficiency, low immunogenicity and wide tropism range of individual serotypes. However, cost-effective manufacturing of clinical grade AAV remains an ongoing challenge. Wild-type AAV requires adenovirus (AdV) helper function to replicate as part of its life cycle. While this process can be efficiently adopted for viral vector production, it results in high level of AdV contamination. This issue can be addressed by providing AdV helper function through a plasmid, however this reduces the efficiency of production. In both cases use of plasmids results in high cost of goods, especially in GMP manufacturing.
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