Table 6.
Comparative costs of clinical-grade and GMP-grade processes.
| Manufacturing Costs (*) | Clinical-Grade | GMP-Grade (Fold) |
| Staff (manufacturing and QC) (28%) | 1 | 3.6 |
| Reagents and disposables (49%) | 1 | 1.9 |
| Externalized QC (sterility, mycoplasma, endotoxin) (11%) | 1 | 5.3 |
| Internal QC (phenotype, karyotype, potency) | 1 | 1 |
| Global process (staff, manufacturing and QC) | 1 (2633 EUR/bag) |
2.5 (6647 EUR/bag **) |
| Extra Costs (*) | Clinical-Grade | GMP-Grade |
| Equipment | 1 | 1.5 |
| Environmental monitoring (routine only, not in operation) | 1 | 7.9 |
| QA staff | 1 | 2 |
| Externalized QC method validation | 0 | EUR ~17,000 |
| Media simulations | 0 | EUR ~4000/run (EUR 12,000/validation and EUR 8000/year |
(*) Manufacturing costs considering a standard culture process in 28 days without a holding step and ending with the banking of frozen aliquots. The extra costs include the fixed costs involved in maintaining the propriety of the structure, as well as costs related to QC method validation and media simulations. (**) One bag of MSCs contains between 80 and 190 × 106 cells.