The webinar will discuss some of the advanced analytical capabilities available to Pharmaron for AAV characterisation.

Key messages:

AAV 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 expression system​
Techniques used routinely for characterisation of other advanced therapies do not necessarily translate to AAV analysis
Understanding of challenges posed based on serotype need to be considered and addressed
New technologies will be important 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?​

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?​

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)​

Introduction to CDMS​
Characterisation of AAV Payload Status​
Future Developments