Scalable Manufacturing of Human Mesenchymal Stromal Cells in the Vertical‐Wheel Bioreactor System: An Experimental and Economic Approach

Mesenchymal stromal cells (MSC) hold great promise for tissue engineering applications and cell‐based therapies. Large cell doses (>1 × 106 cells kg−1) and Good Manufacturing Practices (GMP)‐compliant processes are however required for clinical purposes. Here, a serum‐ and xenogeneic‐free (S/XF)...

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Bibliographic Details
Published in:Biotechnology journal 2019-08, Vol.14 (8), p.e1800716-n/a
Main Authors: Pinto, Diogo, Bandeiras, Cátia, Fuzeta, Miguel, Rodrigues, Carlos A. V., Jung, Sunghoon, Hashimura, Yas, Tseng, Rong‐Jeng, Milligan, William, Lee, Brian, Ferreira, Frederico Castelo, Silva, Cláudia, Cabral, Joaquim M. S.
Format: Article
Language:English
Subjects:
Bioreactors
Cell Culture Techniques - economics
Cell Culture Techniques - instrumentation
Cell Culture Techniques - methods
economic model
ex vivo expansion
Humans
Mesenchymal Stem Cells
mesenchymal stromal cells
Vertical‐Wheel Bioreactor
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Summary:Mesenchymal stromal cells (MSC) hold great promise for tissue engineering applications and cell‐based therapies. Large cell doses (>1 × 106 cells kg−1) and Good Manufacturing Practices (GMP)‐compliant processes are however required for clinical purposes. Here, a serum‐ and xenogeneic‐free (S/XF) microcarrier‐based culture system is established for the expansion of human umbilical cord matrix (UCM)‐ and adipose tissue (AT)‐derived MSC using the Vertical‐Wheel system (PBS‐0.1 MAG; PBS Biotech). UCM and AT MSC are expanded to maximum cell densities of 5.3 ± 0.4 × 105 cell mL−1 (n = 3) and 3.6 ± 0.7 × 105 cell mL−1 (n = 3), respectively, after 7 days of culture, while maintaining their identity, according to standard criteria. An economic evaluation of the process transfer from T‐flasks to PBS‐0.1 MAG shows a reduction in the costs associated with the production of a dose for an average 70 kg adult patient (i.e., 70 million cells). Costs decrease from $17.0 K to $11.1 K for UCM MSC and from $21.5 K to $11.1 K for AT MSC, proving that the transition to Vertical‐Wheel reactors provides a cost‐effective alternative for MSC expansion. The present work reports the establishment of a scalable and cost‐effective culture platform for the manufacturing of UCM and AT MSC in a S/XF microcarrier‐based system.
ISSN:1860-6768
1860-7314
DOI:10.1002/biot.201800716