Enhancing AAV process quality and efficiency: three case studies highlighting the benefits of upgraded analytics on downstream process development

The success of downstream process development for biopharmaceuticals, especially in gene therapy viral vectors, relies heavily on effective analytical tools. These vectors have unique impurities and physicochemical properties along with condensed timelines that require robust analytical support. Increased demand for clinical safety and efficacy, which ties directly to product quality, further drives the need for a deep understanding of the manufacturing process. This article explores three case studies on downstream purification development for AAV vectors, highlighting the importance of analytical resources. Key findings include (1) optimized sample preparation enabled agarose gel analysis of cell lysate nuclease digestion; (2) size exclusion high performance liquid chromatography (HPLC-SE) identified hidden impurities in affinity eluate; and (3) dynamic light scattering (DLS) monitoring mitigated AAV loss during anion exchange chromatography. Overall, enhanced analytical techniques improved process understanding, quality, and efficiency, while also shortening development timelines and cutting costs.

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