Feb
17
2022
On demand

AAV manufacturing process development using fast USP and DSP HPLC analytics

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.

  • AAV is the leading vector in the field of gene therapy and it is therefore crucial to develop a robust and high efficiency platform for its manufacturing. 
  • In-process analytics of vector capsid production is a critical optimization target in development of AAV-based gene therapy products. 
  • In this presentation we introduce a fast at-line HPLC based system that enables analysis of the full and empty capsids ratio directly in the harvest. 
  • Insights about purification will also be discussed.

Aleš Štrancar

Chief Executive Officer, BIA Separations

Ales Štrancar is executive managing director of BIA Separations, now a Sartorius company, since funded in 1998. He is one of the main inventors of the CIM Convective Interaction Media® monolithic columns technology and co-inventor of many analytical methods and purification processes including pDNA, mRNA, AAV, Adeno and other viruses. Aleš is author or co-author of more than 90 scientific papers dealing with separation and purification technologies. He is a co-author of several granted USA patents and their foreign equivalents in the field of biomolecule separations and purification.

SPEAKERS

Aleš Štrancar
Chief Executive Officer at BIA Separations

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