Table 1.

Primary quality attributes

Attributes	Requirements
Cell morphology	Cells grown in 2D conditions shall exhibit growth as colonies with clear boundaries, high nuclear‐cytoplasmic ratios and uniform morphology. Within each colony, cell‐cell contact should be tight.
Cell authentication	Cell lines shall have a known unique genetic profile to facilitate exclusion of cross‐contamination with other cells and confirm donor origin. Human short tandem repeat (STR) analysis shall include the following 16 human‐specific alleles: D3S1358, vWA, FGA, D8S1179, D21S11, D18S51, D5S818, D13S317, D16S539, TH01, TPOX, CSF1PO, D7S820, AMEL, PentaE and PentaD.
Chromosome karyotype	46, XX or 46, XY
Cell viability	≥90% before cryopreservation and ≥60% after resuscitation
Cell markers	Cell surface markers: ≥70.0% of the cell population express any two of the following genes: SSEA3, SSEA4, TRA‐1‐60, TRA‐1‐81, for example, TRA‐1‐81–positive rate ≥70.0% and SSEA4–positive rate ≥70.0%; intracellular markers: OCT4‐positive rate ≥70.0% and NANOG‐positive rate ≥70.0%
Teratoma formation	Shall generate teratomas with cells from all three germ layers
Microorganisms	Shall be negative for fungi, bacteria, mycoplasma, HIV, HBV, HCV, HTLV, EBV, HCMV and TP.