High-throughput, automated analysis of viral vector titer and process related impurities accelerates downstream process development of AAV based gene therapies

Adeno-associated virus (AAV) based vectors have become the go-to platform for delivering gene therapies. Vector production is, however, an expensive and complex process that results in a small volume of highly valuable products. AAV capsid particle titer and impurities levels are critical quality attributes (CQA) in the manufacturing of these vectors. Reducing the levels of bioprocess-related impurities in the downstream purification process is a critical regulatory and safety requirement. As sample volume is often limited and executing accurate and precise bioassays of many different types is time consuming, and labor intensive analytical demand can cause workflow bottlenecks. In this study, we investigated the performance and utility of analyzing 2 AAV serotype viral vector titers plus 3 impurities for each serotype in a single, 5-CD, continuous run (“Gyroplex panel”) using the Gyrolab xPand platform using a combination of kits and assay protocols.

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