Analytical Testing Toolbox for AAV Characterization and Lot Release: Selected Application of Biophysical, HPLC, Immunoassay, and Mass Spectrometry Methods

Time: 9:30 am
day: Day Two


  • Intended Use of AAV test methods for characterization, identity, product and process impurities, content and potency
  • Identity test method options
  • HPLC and Mass Spectrometry-based impurity methods: PEI, Triton-X, Host Cell Proteins
  • ELISA for impurities including HCP and AAVx
  • Content assays for excipients, poloxamer, etc.
  • Biophysical methods including AUC, SEC-MALLS
  • Pathways from initial Characterization through Method Development into Qualification and ICH Validation