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Table 6 Release criteria for the finished product and quality controls performed on the target fraction during the validation process

From: Process development and validation of expanded regulatory T cells for prospective applications: an example of manufacturing a personalized advanced therapy medicinal product

Parameter Validation run Finished product specification
#01 [KD1] #02 [KD2] #03 [LD1] #04 [LD2]
TNC viability nd 97.9% 98.3% 98.9% ≥ 90%
Purity 98.3% 97.6% 89.2% 97.9% > 80%
CD127 Treg cells (%) 94.7% 96.5% 88.9% 97.6% > 80%
FoxP3+Treg cells (%) 91.1% 96.5% 84.6% 88.8% > 80%
CD127FoxP3+ (%) 79.2% 96.1% 84.4% 88.6% > 80%
CD45+CD19+ (%) 0.0% 0.0% 0.0% 0.0% < 2%
CD45+CD56+ (%) 0.1% 0.0% 0.0% 0.0% < 2%
CD45+CD8+ (%) 0.5% 1.5% 0.7% 0.5% < 2%
Residual beads count§ na 405 397 156 < 1000
Microbial growth (sterility)# Sterile (4/4 batches) Sterile (no growth)
Mycoplasma No growth No growth
Endotoxin < 0.3 EU/mL (4/4 batches) ≤ 0.3 EU/mL
  1. All data refers to viable cells
  2. na not available
  3. §Absolute number/30 × 106 TNC target fraction
  4. #After 10 days