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AAV-based gene therapies, while promising for treating genetic diseases, require rigorous quality control through advanced methodologies like TCID50 for infectivity, next-generation sequencing for variant detection, viral clearance studies, and potency assays to ensure safety, efficacy, and regulatory compliance.
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Sequencing techniques play a crucial role in establishing the quality attributes of a variety of therapeutic products. Next generation sequencing (NGS), also known as high-throughput sequencing, has emerged as a useful state-of-the-art method to establish product quality through sequence identity.
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Gene therapy offers the potential to cure untreatable diseases with a single injection. An essential part of the production of AAV vectors is the characterization of potential critical quality attributes using a range of analytical techniques. Learn about a set of novel, robust, and orthogonal methods that can be used to assess identity, purity, and residuals.
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Viral clearance studies for non-enveloped viral vectors have been performed less frequently than those of enveloped viral vectors. For this reason, the virus inactivation steps and the model virus panel for clearance studies may not be as clear. Gain a better understanding of viral clearance studies for AAV vectors.
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