AAV Analytical Toolbox for Stability Assessment
- Selection of suitable Methods
- Analysis of the stability indicating power
- Learnings for formulation development
Bioactivity for AAV Therapeutic
- Matrix Approach
- MoA reflection
- Challenges related to references and control items
Development of USP Standards to Support AAV Therapeutics
- USP development of documentary Standards
- USP development of physical standards
- Future direction of USP standard development for AAV
Building and Breaking AAV Processes
- How is development representative of future manufacturing scale?
- What data can we collect/analyze?
- How do we scale up?
- What tools do we have for making quick decisions?
- Are they worth the potential tradeoffs?
- What happens when something goes wrong?
- How can we be good stewards of time/resources?
Chemistry, Manufacturing and Control (CMC) Testing for AAV Therapeutics
- Identity testing
- Purity testing
- Safety testing