Recorded: March 2023

This webinar will discuss how facility design & operation and advanced analytics, support the manufacturing of viral vectors with focus on speed and quality of drug substance to the clinic.

Agenda

  1. 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
  2. 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
  3. 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
  4. Robust Utilities to maximise up time
    • Rotary USP
    • Ozone on water system distribution
    • N+1 Redudancy
    • Ultrasonic vibration analysis