Pharmaron Gene Therapy Webinar: Flexible Facility for Fast AAV Delivery
This webinar will discuss how facility design & operation and advanced analytics, support the manufacturing of viral vectors with a focus on speed and quality of drug substance to the clinic.
Agenda
Introduction:
- Considerations for successful GT manufacture
- Differences between manufacturing GTs compared to other biologics > broad considerations
- Design of effective development and manufacturing spaces with importance on a modern flexible facility
- Analysing and maximising capacity of our space
- Creating a facility which can manage scale up
- Analytical considerations for GTs > small volumes, GMP compliance
The Flexible Facility
- Project throughput from development to GMP (with continuity of team)
- Flexible product streams for multiple GT projects
- Single footprint for Pilot Plant and GMP to increase speed to Clinic
- Case study – increased speed to clinic
Robust Utilities to maximise up time
- Rotary USP
- Ozone on water system distribution
- N+1 Redundancy
- Ultrasonic vibration analysis
Advanced Analytics
- Complex approach to monitor GT critical quality attributes
- Adapting traditional methodologies to address GT challenges
- Advanced Analytics for QC: Making AUC GMP compliant
- Platform approach to GT: AAV Multi-serotype methods
Moderated by: Derek Ellison, VP Biologics Services Europe, Pharmaron Gene Therapy
Key Opinion Leader: Vaughan Thomas, Ph.D., Bioprocess Consultant, Tillingbourne Consulting
Pharmaron Presenters:
Rob Olliver, Director, Process Sciences
Richard Cooper, Assoc. Director, Project Engineering
Kieron McIntyre, Assoc. Director, Analytical Sciences
This webinar is free to attend