NanoMosaic Tessie platform, based on the novel nanoneedle technology, quantifies any region of interest without size limitation across the AAV genome. The full-length NanoMosaic assay is designed to quantify the entire full-length transgene accounting for the ‘therapeutic genome’ and determine its titer accurately and precisely.

Highlights

• The genomic titer of the intact, full-length transgene (3.3kb) is compared to that of truncated species, highlighting disadvantages and limitations of some common approaches such as ITR-based tittering where quantification requires caution in selecting standards and interpreting the data.
• Several new or lesser-discussed attributes of interest and potential targets of process optimization are presented, including the ability to independently identify left vs. right truncation events with a process-development-friendly analytical tool, and relevant approaches to interpret them in relation to other species.
• The nanoneedle technology presents an attractive approach for quantifying the true full-length transgene of interest and identifying pools of partials that can persist in AAV feed streams throughout the manufacturing process.
• The ratio of full-length vs. total packaged viral genome species is proposed as a measure for assessing AAV product quality and manufacturing performance in an effort to emphasize the impact of packaged truncated species and distinguish from the typical % full measurement.

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