Strategies for Scale-up & Scale-out
Guest Editor: Prof. Nik Willoughby, Heriot-Watt University, UK
This spotlight examines the latest innovative solutions and critical issues around product scale-up and scale-out. Discussions center around the following topics:
- Key cost drivers of scalability and measures to overcome comparability and scale-up challenges in cell therapy production.
- Process development technologies and facility design options for scale up of allogeneic cell therapies and approaches for GMP-compliant scale up platforms.
- Advances in microfluidic technologies for the scale up of cell and gene therapies.
- Manufacturing models and regulatory considerations for the scale out of autologous cell therapy products;
- Challenges in developing scale-out manufacturing processes.
Commercial Lessons for Clinical Success
Strategies for Scale-up & Scale-out: Full Spotlight
Biopharma scale-up lessons to learn for cell & gene therapy
Towards commercial allogeneic cell therapy manufacturing
Critical considerations for allogeneic cell therapy scale up
Scale-up of a perfusion-based dendritic cell generation process
The long road to affordability: a cost of goods analysis for an autologous CAR-T process