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Quality control for AAV-based gene therapies is evolving quickly, and regulatory expectations are becoming more exacting. Explore essential QC strategies in AAV gene therapy and how to address rcAAV detection and impurity profiling using NGS to meet evolving regulatory demands.
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Combining the strengths of both sequencing methods can help deliver clearer genome assemblies. Gain insights into utilizing hybrid long-read and short-read sequencing to analyze adeno-associated virus capsids to enhance biosafety testing while achieving high identity mapping.
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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 compliance.
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Learn how to pinpoint potential sources of viral contaminants, establish manufacturing steps to remove or inactivate contaminants, and make key distinctions between designing a viral clearance study for non-enveloped viral vectors versus those for mAbs or recombinant proteins.
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AAV Gene Therapy Characterization & Release Testing
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Backed by decades of GMP testing and regulatory expertise, we deliver the flexibility and support you need to propel the execution of your quality control strategy from first-in-human trials to commercialization. Explore our broad capabilities to learn why leading gene therapy companies rely on us for their testing needs. Learn more here.
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