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Table 1 Quality product profile for hPO. Critical quality attributes of hPO and acceptance proposed by Dossena and collaborators that can be adapted in other developments of organoid production in accordance with pharmaceutical quality standards. Additional controls may include determination of endotoxins, mycoplasma, and sterility test according to the pharmacopeia. Ab antibody, Ag antigen, HBc hepatitis B core, HBV hepatitis B virus, HCV hepatitis C virus, HIV human immunodeficiency virus, VDRL-TPHA venereal disease research laboratory test-treponema pallidum hemagglutination test

From: The challenge of developing human 3D organoids into medicines

In process controlsAcceptance criteria
Donor
 Serology (HIV, HBV, HCV, anti-HBc, VDRL-TPHA)Negative
 Risk factors, systemic infections, diabetesAbsence
 Amylase levelsWithin 3 times the normal range
Biopsy
 Transport21 ± 4 °C
hPO
 IsolationWithin 36 h from biopsy
 Identity (using ductal, mesenchymal, hematopoietic and endothelial markers)Presence of ductal progenitors (PDX1+/SOX9+)
 MetabolismNormal glucose consumption and lactate production
 Viability≥ 70%
 PotencyCapacity to differentiate into insulin-secreting cells
 Sterility (BacTAlerT)Sterile
 KaryotypeNormal