Table 1.
Acceptance criteria for the manufacturing of clinical-grade WJ-MSCs.
| In-process quality control | Acceptance criteria | Manufacturing process |
|---|---|---|
| UC blood | Serology: HBsAg, HIV I/II, Lues (TPHA), Chagas, anti-HBc, HCV, anti-HTLV I/II, NAT (HCV-HIV, HBV) | Negative |
| WJ-MSC expansion step and scale-up to DP | Dose | ≥2·5 × 107 ± 20% viable cells/cryotube |
| Viability | ≥70% | |
| Karyotype | Non-chromosomal abnormalities | |
| CD105+/CD45− (%) | ≥95% | |
| CD73+/CD31− (%) | ≥95% | |
| CD90+ (%) | ≥95% | |
| HLA-DR− | Informative* | |
| Mycoplasma | Negative | |
| Endotoxin | ≤1 EU/mL | |
| Sterility | Sterile | |
| Adventitious virus | Negative | |
| Immunomodulation (Potency assay) | >30% Inhibition of PBMC proliferation |
Note: DP, drug product; EU, endotoxin units; HBsAg, hepatitis B surface antigen; HBc, hepatitis B core antigen; HBV, hepatitis B virus; HCV, hepatitis C virus; HTLV, human T-cell leukemia-lymphoma virus; HIV, human immunodeficiency virus; NAT, nucleic acid test; PBMC, peripheral blood mononuclear cell; TPHA, Treponema pallidum hemagglutination assay; UC, umbilical cord; WJ-MSCs, Wharton's jelly mesenchymal stromal cells.
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HLA-DR for informative purposes only.