Assessment of Pall's Xpansion® bioreactor for the production of mesenchymal stromal cells for therapeutic use

• Published in: Cytotherapy (Oxford, England) Vol. 22; no. 5; pp. S99 - S100
• Main Authors: Rouard, H., Kadoch, J., Lecuyer, M., Mary, T., Meyer, A., Segier, J., Cameau, E., Birebent, B.
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.05.2020
• ISSN: 1465-3249; 1477-2566
• DOI: 10.1016/j.jcyt.2020.03.175

Mesenchymal Stromal Cells (MSCs) are involved in several clinical trials in the field of Advanced Therapeutic Medicinal Products (ATMPs) for their properties and therapeutic potential. However, the production of MSCs is currently done in multi-plates culture chambers (CellSTACK, Corning) that only allow the production of a limited number of cells and it's time consuming. This therefore represents a constraint, especially for allogeneic uses. Now, the major challenge is to increase this production capacity. The use of a bioreactor would overcome this problem. The Xpansion® bioreactor (Pall) is composed of a controller and single-use bioreactors. Similar in concept to CellSTACK, the Xpansion bioreactors are composed of stacked cell culture plates that are sold in four variations: 10, 50, 100, and 200. Although the plastic of the bioreactor plates is identical to those of the CellSTACK, the feasibility and equivalence of quality and expansion of the MSCs produced using the Xpansion bioreactor had to be demonstrated. Preliminary tests were carried out on the smallest model of the Xpansion bioreactor product line: The XP10 (10 culture plates). All experiments were performed in parallel with a CellSTACK manipulation. The tests were performed using MSCs at passage 0 (from bone marrow or adipose tissue) or raw materials. Quantitative and qualitative tests were carried out at the end of the culture. From raw material or MSCs, cell densities obtained after 6 days of culture are equivalent in both the Xpansion bioreactor and CellSTACK, demonstrating similar cell growth. The average cell expansion rates in the Xpansion (XP10) bioreactor and CellSTACK are 24.39 times and 21.69 times (n=3), respectively. The flow cytometry analysis showed that the phenotype and viability of the MSCs from the bioreactor were not altered by this culture method. Preliminary tests on the Xpansion bioreactor have demonstrated the feasibility of MSCs cell expansion without affecting the quality of the finished product compared to the current method in CellSTACK. In addition, using a bioreactor allows the production of cells in large quantities by managing only one culture chamber while reducing the risk of contamination and operation time. Additionally, using a bioreactor improves monitoring of culture parameters and scalability. Manufacturing MSCs in this bioreactor would make the graft of a larger number of patients from the same initial collection possible.