Recorded: April 2022

This webinar will discuss some of the AAV advanced analytical capabilities available to Pharmaron for AAV characterization.

Key messages on AAV Advanced Analytics: 

  • AAV advanced analytical testing must overcome a range of challenges associated with the complexity of the viral vector format: ​
    • High molecular mass and level of heterogeneity (capsid composition, payload e.g., empty, partial, full)​
    • Diverse range of post-translational modifications​
    • Host cell protein from the expression system​
  • Techniques used routinely for the characterization of other advanced therapies do not necessarily translate to AAV analysis
  • Understanding of challenges posed based on serotype needs to be considered and addressed
  • New technologies will be critical in meeting some of the challenges of AAV analysis e.g., mass photometry, CDMS, IMS-MS

Agenda: 

  1. What are the challenges associated with AAV analytics?  (KOL)​
    • Heterogeneity and mass of AAV material​
    • Post-translation modifications and CQA identification​
    • Protease resistance of particular AAV serotypes​
    • HCP detection​
  2. What is Pharmaron’s current approach? (Pharmaron)​
    • Peptide mapping approach for sequence and PTM determination​
    • Intact mass methods for identity confirmation and potential PTMs​
    • Innovative approach to protease digestion​
    • Leverage of wide-ranging technologies ​
    • Collaborative approach to method development and assessment of new technologies​
  3. Charge Detection Mass Spectrometry (CDMS) (University of Manchester)​
    • Introduction to CDMS​
    • Characterization of AAV Payload Status​
    • Future Developments