Fraunhofer Institute for Cell Therapy and Immunology IZI
Workshop: AAV-GMP Process Analysis
Date
July 17, 2025
Time
10 a.m. to 12 p.m.
Host
Dr. Thomas Schmid (Fraunhofer IZI) & Dr. Jaqueline Breuer (Fraunhofer IZI)
Location
Online (Registered participants will receive the link by email shortly before the event)
Topics
GMP basics for AAV development
- What is GMP?
- Why do we need it?
- Differences between R&D and GMP?
- What should be considered in GMP-compliant process development?
AAV-GMP process analysis
- basic process steps
- how to organize these
- create a professional flow chart
FMEA risk analysis
- Why do we need it?
- Tools for the first steps
- Example file for FMEA
Identification of critical process parameters
- What is Quality by Design?
- Typical CPPs and CqAs for AAV
- Why does Design of Experiments improve our process Development?
GMP checklist for materials and equipment
- Typical errors in the choice of material
- Checklist