Scale-Up of Academic Mesenchymal Stromal Cell Production
Abstract
:1. Introduction
2. Materials and Methods
2.1. GMP-Compliant Isolation and Expansion of MSCs
2.2. Continuous Production (CP)
2.3. Discontinuous Production (DP)
2.4. Environmental Monitoring
2.5. MSC Quality Controls
2.5.1. Infectious Markers
2.5.2. Microbiological Controls
2.6. MSC Characterization According to the ISCT Guidelines [24]
Cell Count and Immunophenotype Analysis
2.7. Clonogenicity Assays
2.8. Mixed Lymphocyte Reaction (MLR)
2.9. Mesodermic Differentiation
2.10. Karyotype and Telomerase Activity
2.11. Senescence Assay
2.12. Statistics
3. Results
3.1. Production Data from the MSC Manufacturing Process
3.2. Particle Controls in the Production Environment
3.3. Quality Control Data from the MSC Manufacturing Process
3.4. Comparison between MultiPL30i and MultiPL100i
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Continuous | Reception | P0 | P1 | P2 | P3 | |
Donor infectious markers | Bacteriology CFU-F Cell phenotype Count/Viability | Bacteriology Cell phenotype Karyotype CFU-F Count/Viability Telomerase activity MLR Osteocyte and adipocyte differentiation (first 3 batches) | ||||
Discontinuous | Reception | P0 | P1 | P2 | Cryopreservation/Thawing | P3 |
Donor infectious markers | Bacteriology CFU-F Cell phenotype Count/Viability | Bacteriology Count/Viability | Bacteriology Cell phenotype Karyotype CFU-F Count/Viability Telomerase activity MLR Osteocyte and adipocyte differentiation (first 3 batches) |
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Laroye, C.; Gauthier, M.; Morello, J.; Charif, N.; Cannard, V.L.; Bonnet, C.; Lozniewski, A.; Tchirkov, A.; De Isla, N.; Decot, V.; et al. Scale-Up of Academic Mesenchymal Stromal Cell Production. J. Clin. Med. 2023, 12, 4414. https://doi.org/10.3390/jcm12134414
Laroye C, Gauthier M, Morello J, Charif N, Cannard VL, Bonnet C, Lozniewski A, Tchirkov A, De Isla N, Decot V, et al. Scale-Up of Academic Mesenchymal Stromal Cell Production. Journal of Clinical Medicine. 2023; 12(13):4414. https://doi.org/10.3390/jcm12134414
Chicago/Turabian StyleLaroye, Caroline, Mélanie Gauthier, Jessica Morello, Naceur Charif, Véronique Latger Cannard, Céline Bonnet, Alain Lozniewski, Andrei Tchirkov, Natalia De Isla, Véronique Decot, and et al. 2023. "Scale-Up of Academic Mesenchymal Stromal Cell Production" Journal of Clinical Medicine 12, no. 13: 4414. https://doi.org/10.3390/jcm12134414