AAV Manufacturing Process Development Using Fast USP and DSP Biochromatography Analytics

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 PATfix 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.

Ales Strancar, Managing Director, Sartorius BIA Separations

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