Table 3: Summary of release data in 8 ATMP-CD133 batches.

Release testResultsAcceptance criteria
MeanStandard deviationMedianRange

Purity (%)88.86±6.2190.6081.40–96.20≥50%
Viability (%)99.13±1.4799.8796.03–99.97≥70%
Cellularity (×106)10.37±9.089.692.85–30.84≥1.0 × 106
SterilitySterile (8/8 batches)Sterile
Endotoxin<0.5 EU/mL (8/8 batches)<0.5 EU/mL
MycoplasmaAbsent (8/8 batches)Absent