The goal of gene therapy is to introduce new genetic material into target cells without toxicity to non target tissues. Advanced delivery technologies play a key role here and these broadly include two categories of vectors; viral and non-viral. As the cell and gene therapy field continues to evolve and products enter clinical development, the need for appropriate analytical tools is critical to achieving well-characterized products, this includes a requirement to ensure quality control of the delivery system as well as the drug substance. Robust analytical technologies which can drive insight into critical quality attributes can ensure a better understanding and control during the manufacturing process.

This presentation describes a range of techniques you can apply to characterization and quality control testing for either viral vectors, such as AAVs, and liposomal technologies and key considerations for deploying these approaches to monitor quality attributes, ensuring a safe, high quality, consistent and efficacious product.

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