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 controls | Acceptance criteria |
|---|---|
Donor | |
Serology (HIV, HBV, HCV, anti-HBc, VDRL-TPHA) | Negative |
Risk factors, systemic infections, diabetes | Absence |
Amylase levels | Within 3 times the normal range |
Biopsy | |
Transport | 21 ± 4 °C |
hPO | |
Isolation | Within 36 h from biopsy |
Identity (using ductal, mesenchymal, hematopoietic and endothelial markers) | Presence of ductal progenitors (PDX1+/SOX9+) |
Metabolism | Normal glucose consumption and lactate production |
Viability | ≥ 70% |
Potency | Capacity to differentiate into insulin-secreting cells |
Sterility (BacTAlerT) | Sterile |
Karyotype | Normal |