How Can Platform Approaches to CMC Development Improve AAV Production and Scale-Up for Viral Vectors?
On-Demand Webinar
Original Date: November 19, 2024
8 am PST / 11 am EST / 4 pm GMT
This webinar will discuss Pharmaron’s approach to developing and scaling up the Pharmaron AAV Production Platform, the benefits of applying the platform, and how this can accelerate AAV products to BLA/MAA submission.
Agenda
1. Introduction to AAV
- AAV as a therapeutic
- Importance of serotype
- Key considerations of platform (cell line, plasmids, manufacturing process)
2. Overcoming Common AAV Production Challenges
- Yield
- Production quality
3. Effective Scale-Up of AAV Manufacturing Processes
- Transitioning from bench to production scale for clinical manufacture
- Pharmaron Platform data overview
4. Platform Lifecycle Development
- Continuous improvements of the AAV Production platform driven by innovation
- Case Studies
5. Summary
- Recap of key points
Moderated by:
Derek Ellison – VP of Biologics Services Europe at Pharmaron
Speakers
Guest Speaker - Prof. Gary Lye - Director of Manufacturing Futures Lab, UCL East
Gary is Director of UCL East Manufacturing Futures Lab, Director of EPSRC Centre for Doctoral Training in Bioprocess Engineering Leadership and Co-Director of EPSRC Cellular Agriculture Manufacturing Research Hub and the UK Medicines Manufacturing Skills Centre of Excellence. He was previously Head of the UCL Department of Biochemical Engineering.
Gareth Berry - Senior Scientist, Process Sciences at Pharmaron
Gareth Berry is a Downstream Development Senior Scientist with over a decade of experience in biopharmaceuticals, focusing primarily on viral vaccines and gene therapies. Currently, he is the in-lab lead for various client projects.
Shandel Pariag - Senior Scientist, Process Sciences at Pharmaron
Shandel Pariag is a Senior Process Scientist at Pharmaron Biologics and has contributed to establishing the Upstream AAV platform. He leads projects for developing, optimizing, and scaling upstream AAV production processes and is a technical lead for continuous platform improvement through innovation.