Adeno-associated virus (AAV) is a pivotal vehicle for in vivo gene therapy due to its non-pathogenic nature and tissue-specific tropisms. However, low upstream titres, high degrees of similarity between the product and product-related impurities, immaturity of manufacturing technologies and limited process understanding and experience of manufacturing AAV at scale result in highly inefficient processes with typical downstream process yields of 10 - 50 % being reported.
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