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Bespoke cell therapy manufacturing platforms
- Levinson, Yonatan, Beri, Rajesh G., Holderness, Kathryn, Ben-Nun, Inbar Friedrich, Shi, Yaling, Abraham, Eytan
- Biochemical engineering journal 2018 v.132 pp. 262-269
- bioreactors, cell culture, humans, manufacturing, stem cells, stromal cells, therapeutics
- There is an emerging need for flexible platforms capable of manufacturing cell products at large scale for both allogeneic and autologous therapeutics. These platforms must be capable of both scaling up and scaling out, while maintaining control over the cell culture environment and process steps. We describe two platform designs: a microcarrier-based bioreactor platform capable of scaling up manufacturing of adherent cell types, such as mesenchymal stromal cells and human pluripotent stem cells (embryonic and induced), as well as a modular device capable of performing an entire cell therapy manufacturing process within a self-contained unit. These platforms are inherently adaptable to multiple cell types and process variations while simultaneously offering consistency, thereby appealing to both the developers of novel therapies as well as the manufacturers.