ASGCT 2024

Join us for the presentation by Rok Žigon (Wednesday, May 9 at 8:00am in the Room 337-338) and visit our experts in exhibit hall at booth number 1616.

Title:

From Process Development to Manufacturing – How to Successfully Optimize and Scale up the AAV Enrichment Step on Novel CIMmultus QA HR Line

Abstract:

Adeno-associated viruses (AAV) have emerged as leading vectors for gene therapy applications due to their low pathogenicity and ability to mediate long-term gene expression in a wide range of tissues. In each AAV downstream process, one of the key and often a bottleneck, step is enrichment of full capsids.  Along with scalability and capsid’s separation challenges one should account for sample heterogeneity and assess which analytics are adequate to distinguish between AAV sub-populations to deliver only the potent AAV product.

To address the recent needs Sartorius BIA Separations developed new CIMmultus HR line (HR stands for High Reproducibility) columns with better resolution and narrower acceptance criteria. These columns allow for batch-to-batch and scale-to-scale reproducibility within just 3% of the AAV8 empty capsid iso-conductivity elution. Such columns allow for step gradient elution using the same buffer strength at any scale. Two order of magnitude removal of empty capsids should be possible.

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