Analytical Tools to Improve Empty/Full Ratio in Initial Stages of AAV Process Development

Time: 11:30 am
day: Day One


  • Empty AAV capsids are known contributors of immunogenicity in gene therapy products
  • Reducing them below 10% during downstream process is difficult if empty capsids constitute vast majority of total AAV produced in harvest. The solution is further optimization of harvest production
  • Determining the factors that improve empty/full ratio is possible already at the initial stages of upstream process development, with utilization of at-line HPLC system that measures E/F ratio directly in harvest samples. The same tool can be used for in-process control, to track the AAV production in samples collected during manufacturing runs
  • Described HPLC analytics is suitable for wide variety of samples, which allows easy link-up of upstream with downstream process development, and overall more holistic approach to AAV bioprocess