7.1.1 As with any biologic drug substance and drug product, raw material analysis, in-process monitoring, and product-release testing are essential to ensuring the quality and safety of AAV vectors used for gene therapy.
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7.2.1 As with any biologic drug substance and drug product, raw material analysis, in-process monitoring, and product-release testing are essential to ensuring the quality and safety of LV vectors used for the production of genetically modified cell therapies.
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7.3.1 One of the remaining significant challenges to the development of gene and gene-modified cell therapies relates to the lack of analytics designed specifically for viral vector characterization. For AAV vectors, in addition to identity, viral titer, and other expected measurements, the ratio of full to partial and empty capsids must be determined, as the latter can lead to immunogenic responses. Detection of any capsids containing undesirable host cell or plasmid DNA is equally important, as they could potentially be toxic.
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