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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.