A scalable xeno-free microcarrier suspension bioreactor system for regenerative medicine biomanufacturing of hMSCs
January 27-31, 2019
An economical biomanufacturing paradigm for human mesenchymal stem/stromal cells (hMSCs) is in critical need, as indicated by over 800 clinical trials investigating the use of hMSCs for regenerative medicine. To meet the demand for clinical manufacturing, a scalable process and production technology platform that can generate billions to trillions of cells per manufacturing lot is needed. Suspension bioreactors show great promise in reaching commercially-viable working volumes, however, scalability of cell production remains an issue. Overcoming this challenge is necessary to drive widespread adoption of this culture system for hMSCs. We have taken the Quality by Design (QbD) approach to develop a scalable xeno-free (XF) hMSC bioreactor process that maintains the final cell population doubling level (PDL) within the recommended range of 16-20 to ensure product quality. Our strategic XF bioprocess was designed using high volume XF cell banks, an optimized XF fed-batch media system, and XF microcarriers, all combined in a scalable bioreactor system to meet our design criteria and streamlined production at different culture scales.
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Josephine Lembong, David Wang, Robert Kirian, Ang-Chen Tsai, Kenny Cruz, Francisco Rosello, Kayley Cox, Yas Hashimura, Sunghoon Jung, Taby Ahsan, Jon Rowley, and Timothy Olsen, "A scalable xeno-free microcarrier suspension bioreactor system for regenerative medicine biomanufacturing of hMSCs" in "Advancing Manufacture of Cell and Gene Therapies VI", Dolores Baksh, GE Healthcare, USA Rod Rietze, Novartis, USA Ivan Wall, Aston University, United Kingdom Eds, ECI Symposium Series, (2019). http://dc.engconfintl.org/cell_gene_therapies_vi/55