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Table 5 Final product release criteria

From: Manufacturing and banking canine adipose-derived mesenchymal stem cells for veterinary clinical application

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