AAV manufacturing process development using fast USP and DSP HPLC analytics
Event: Cell and Gene Therapy Insights webinar
Date: February 17, 2022
Presenter: Ales Strancar, Managing Director
Key learning points:
- One of the key challenges in manufacturing viral vectors is to increase the ratio between empty and full capsids.
- When the expression in the cell line results in less than 10% full capsid it is quite impossible to reach better than 90% full in the final product. It is therefore mandatory to optimise the USP to result in better empty/full ratio.
- This can be efficiently realised by using at-line HPLC to allow for analysis of the full and empty capsids ratio directly in the harvest.
- The residual empty capsids can be removed by polishing step using different anion exchange columns.