Spotlight on gene therapy analytical testing

Gene therapies are transforming healthcare, offering innovative approaches to treat a wide range of conditions. Plasmid DNA serves as an essential starting material in AAV manufacturing. However, limited guidance on plasmid quality control presents challenges in plasmid production, characterization, safety, efficacy and standardization of gene therapy products.

This Spotlight feature will explore the role of gene therapies in addressing unmet medical needs and the strategies for enhancing plasmid quality control. We will also explore the key considerations for plasmid manufacturing and analytical characterization, providing manufacturers with the insights needed to establish an effective control strategy for plasmid DNA used as a starting material for gene therapies.

This feature was produced in association with USP Biologics.