A Holistic Approach to AAV Advanced Analytics

Capabilities
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:
- 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
- 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
- Charge Detection Mass Spectrometry (CDMS) (University of Manchester)
- Introduction to CDMS
- Characterization of AAV Payload Status
- Future Developments