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Table 2 Specifications and results from GMP batch analysis (n = 13)

From: Process development and safety evaluation of ABCB5+ limbal stem cells as advanced-therapy medicinal product to treat limbal stem cell deficiency

Parameter Test method Specification Mean Deviations from specification
Absolute Percentage
ABCB5+ cell content Flow cytometry ≥ 90% 96.4% 0 0%
Mycoplasma Nucleic acid test-based assay (2.6.7 Ph. Eur.) not detectable (<  10 CFU/ml) <  10 CFU/ml 0 0%
Endotoxin level LAL-Test (2.6.14 Ph. Eur.) ≤ 2 EU/ml ≤ 2 EU/ml 0 0%
Cell vitality Flow cytometry (2.7.29 Ph. Eur.) ≥ 90% 97.5% 1 7.7%
Cell viability Flow cytometry (2.7.29 Ph. Eur.) ≥ 90% 99.2% 0 0%
Bead residues Flow cytometry ≤ 0.5% 0.04% 0 0%
Microbiological control (n = 12)a) BacT/ALERT® System (adapted to 2.6.27 Ph. Eur.) no growth n.a. 0 0%
p63+ cell content Immunofluorescence ≥ 20% 76,7% 0 0%
PAX6+ cell content (n = 8)b) Immunofluorescence ≥ 50% 71.3% 0 0%
  1. Ph. Eur. European Pharmacopeia, LAL Limulus amebocyte lysate, n.a. not applicable
  2. aOne batch could not be evaluated due to sample size error and was therefore not released
  3. bFive batches could not be evaluated due to staining problems and were therefore not released