Allogeneic cell therapy manufacturing: process development technologies and facility design options

Currently, promising outcomes from clinical trials of allogeneic cells, especially allogeneic mesenchymal stromal cells, fibroblasts, keratinocytes, and human cardiac stem cells, have encouraged research institutions, small and medium enterprises (SMEs), and big pharmaceutical companies to invest and focus on developing allogeneic cell therapy products. Commercial and large-scale production of allogeneic cell therapy products requires unique capabilities to develop technologies that generate safe and effective allogeneic cells/cell lines and their fully characterized master/working banks. In addition, it is necessary to design robust upstream and downstream manufacturing processes, and establish integrated, well-designed manufacturing facilities to produce high quality affordable products in accordance with current GMP regulations for the production of cell therapy products. Areas covered: The authors highlight: the recent advances in the development of allogeneic products, the available options to develop robust manufacturing processes, and facility design considerations. Expert opinion: Currently, there are multiple challenges in development of allogeneic cell therapy products. Indeed, the field is still in its infancy; with technologies and regulations still under development, as is our understanding of the mechanisms of action in the body and their interaction with the host immune system. Their characterization and testing is also an emerging and very complex area.