Table 5 Final product release criteria
Specification | Expected | Methods |
|---|---|---|
Cell counts | 1.0 × 106 /kg | Automatic cell counter |
Viability | ≥ 90 % | Trypan blue staining |
Sterility | No growth | Microbiology culture |
Mycoplasma | Negative | Culture |
Endotoxin | > 0.5 EU/mL | Limulus Amebocyte Lysate |
Phenotype (CD29, CD34, CD44, CD45 and CD90) | ≥ 95 % CD29, CD34, CD90 ≤ 2 % CD34, CD45 | Flow cytometry |
Differentiation potential | Osteogenesis, adipogenesis | Induction culture |
Karyotype analysis | 39 pairs of chromosomes | Giemsa staining |
Tumorigenicity | Negative | Injection into nude mice |