Strategies for Scale-up & Scale-out
Guest Editor: Prof. Nik Willoughby, Heriot-Watt University, UK This spotlight will examine the latest innovative solutions and critical issues around product scale-up and scale-out. Discussions will be centered 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.