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

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; Roadways to meet net carbon zero by 2050.

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 Redundancy; Ultrasonic vibration analysis

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;
Kieron McIntyre, Assoc. Director, Analytical Sciences;
Richard Cooper, Assoc. Director, Project Engineering