TABLE 2.

Testing and methodology requirements for final product release

Test	Test Method	Specification
Safety
Bacterial (aerobic, anaerobic) & fungal testing	Sterility testing (outsourced to analytical lab) per 21 CFR 610.12	Sterile
Gram stain	Gram stain	Negative
Bacterial endotoxin	LAL method by Endosafe PTS	<0.2 EU/kg of recipient’s body weight
Mycoplasma	RT-PCR	Negative
	Culture based per 21 CFR 610.30	Negative
Purity/identity
Cell count & viability	Cell count & viability assay: using SYTO24 and SYTOX Green	VCC ≥ 100–150 × 106 cells, viability ≥80%
Purity	FACS	CD271+ cells ≥90%
Microscopic exam of cultures	Inverted bright-field microscopy	Bipolar spindle-shaped SCs

FACS = fluorescence-activated cell sorting; LAL = limulus amebocyte lysate; PTS = portable testing system.