Table 1 Scale-up feasibility of stem cells growth in Xpansion bioreactor.
From: Scale-up of hepatic progenitor cells from multitray stack to 2-D bioreactors
QUALITY CONTROL TEST | Xpanion10 (Five runs) | Xpansion 50 (Two runs) | Xpansion 180 (Three runs) | In-Line Centrifugation Three runs |
|---|---|---|---|---|
CELL CULTURE SURFACE (CM2) | 6.120 | 30.600 | 110.160 | / |
AVERAGE CELL QUANTITY AT HARVEST | 1.8 × 108 | 9 × 108 | 3.3 × 109 | / |
VIABILITY | ≥90% | ≥90% | ≥90% | ≥90% |
GROWTH PROFILE | Normal | Normal | Normal | Normal |
CONFLUENCY | √ | √ | √ | √ |
HOMOGENEOUS CELL DISTRIBUTION & MORPHOLOGY | √ | √ | √ | √ |
IDENTITY CYP3A4 Activity | Conform > 10-8pmol/cell/4 h | Conform > 10-8pmol/cell/4 h | Conform > 10-8pmol/cell/4 h | Conform > 10-8pmol/cell/4 h |
IDENTITY Phenotype | Conform CD73, CD90>60% ALB+, vim+, ASMA+ | Conform CD73, CD90>60% ALB+, vim+, ASMA+ | Conform CD73, CD90>60% ALB+, vim+, ASMA+ | Conform CD73, CD90>60% ALB+, vim+, ASMA+ |
PURITY | Conform CD31+CD133+ CD45+CK19 < 15% | Conform CD31+CD133+ CD45+CK19 < 15% | Conform CD31+CD133+CD45+CK19 < 15% | Conform CD31+CD133+CD45+CK19 < 15% |
POTENCY (Urea secretion) | ConforM 4/5* | ConforM 1/2* | Conform 3/3 | Conform 3/3 |
POTENCY (Bilirubin Conjugation) | Conform 4/5* | Conform 2/2 | Conform (pending) | Conform (pending) |