Establishing Product Quality Standards for AAV Vectors to Enable Smooth Gene Therapy Regulatory Filing

Time: 1:45 pm
day: Day Two


  • Highlighting the significance of holding and understanding CQAs early on to allow comparability throughout process changes and batch
  • Outlining the landscape of regulatory expectations for viral vectors, such as contaminant levels of host protein, adventitious virus, and empty/full specifications
  • How can you best defend your product meeting critical attributes with regulatory bodies?