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Bioanalysis of adeno-associated virus gene therapy therapeutics: regulatory expectations

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In this perspective article, published by Bioanalysis, the authors present the current regulatory recommendations for bioanalytical support of adeno-associated virus-based gene therapy development.  This article was published as part of the special focus issue, ‘The Exciting World of Oligonucleotides.’ 

Keywords: gene therapygenome integrationimmune responseinfectivityneutralizing antibodytotal antibodytransgene proteinviral vector shedding

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