The fast-growing gene therapy industry is in pressing need for fast and reliable analytical methods to accelerate bioprocess development and manufacturing of AAV viral vectors.

Matt Lotti, Senior Research Associate II at Ultragenyx, a pharmaceutical company developing therapies for patients with rare genetic diseases, will present how the Analytical Development team at Ultragenyx developed a Gyrolab-based assay that demonstrates acceptable accuracy and precision for supporting in-process testing of AAV8 capsid titer.

The automation-based capsid titer assay enabled the reduction of costs and materials, provided improved assay throughput, and expanded the assay dynamic range.

Learning Objectives:

• Insight on the needs in AAV development, manufacturing and analytics.
• Accurate determination of AAV capsid titer in process intermediate samples that are low in concentration and/or high in impurities levels.
• Learn how automated analytical solutions, such as the Gyrolab platform can boost throughput in analytical labs with faster, more accurate, and more reproducible assay results.