Title

Robust Manufacturing of Purer AAV Gene Therapy Vectors

Abstract

The main goal of AAV downstream process (DSP) is to achieve high recovery of >90% full AAV capsid. For the 1^st column step either affinity or cation exchange chromatography is used. For the polishing anion exchange chromatography or ultracentrifuge is employed.

In this webinar comparison of the cation exchange and affinity column will be presented.

To address the recent needs the new CIMmultus HR line (HR stands for High Reproducibility) columns with better resolution and narrower acceptance criteria used for the polishing step will be shown.

Key Learning Points:

• 10% improved process recovery using the strong cation exchange instead of affinity column
• up to 2 fold shorter processing time using SO3 instead of affinity column
• less damaged capsids using SO3 instead of affinity column
• >5times better resolution of the empty/full capsids by applying new methods with the QA anion exchange columns

The QA HR columns allow for batch-to-batch and scale-to-scale reproducibility within +/- 3%; about 10 better when compared with the traditional CIMmultus line

Speaker