Several topics are covered around the optimization of manufacturing scale-up of therapeutic viral vectors to support advanced clinical trials and commercialization.
Webinar on process development to manufacturing scale-up of therapeutic viral vectors
0:19 Introduction to the webinar
2:10 Presentation of Polyplus-transfection
2:57 Transfection product lines
3:56 Viral Vectors Manufacturing Roadmap
6:59 Current Upstream Manufacturing Challenges
8:15 Optimized PEI for Viral Vector Production: PEIpro® product range
12:02 Scaling-up systems: adherent and suspension
14:00 Scalable transient transfection: cell culture medium
18:35 Production scale-up
21:20 PEIpro® product range: from PD with PEIpro® to commercialization with PEIpro®-GMP
24:40 Experiences of viral vector manufacturing and specific pain points in scaling-up
29:45 Adherent VS suspension
36:30 Transfection efficiency factors, which criteria need to be monitored in a dynamic process?
42:50 Importance of supplier relationships as you move to commercial scale?
49:30 Could regulatory agencies ask for a QC on residual presence of PEIpro® within the final product?
50:17 Is Metabolomic used to understand the bioprocess system and how efficient transfection is?
52:55 What further improvements to look for in viral vector manufacturing process?