Table IV.
Release criteria for the TC-NK products.
| Test | Method | Criteria | Results available within 7 days after cryopreservation |
|---|---|---|---|
| USP sterility1 | Immersion USP 21 CFR 610.12 bacterial and fungal sterility test | Negative after 14 days | No |
| Sterility1 | Gram stain | No organism seen | Yes |
| Sterility1 | BACTEC for aerobic, anaerobic bacteria and fungus | No growth | Yes (preliminary) |
| Bacteria, fungus | |||
| Sterility1 | Endosafe PTS (LAL) | < 5.0 EU/mL | Yes |
| Endotoxin | |||
| Mycoplasma2 | Polymerase chain reaction (Takara) | Negative | Yes |
| Purity3 | Flow cytometry | < 0.1% GFP+ K562-mbl5-41BB-L feeder cells | Yes |
| Purity3 (only for allogeneic) | Flow cytometry | < 2 × 105 CD3+ CD56− cells/kg | Yes |
| Purity3 (only for autologous) | Flow cytometry | > 50% CD56+ CD3− cells | Yes |
| Purity3 (only for allogeneic) | Flow cytometry | > 70% CD56+ CD3− cells | Yes |
| Identity3 | HLA class I (A, B) genotyping | Identical to NK donor | Yes |
| Potency3 | Cytotoxic activity to K562 cells | > 20% lysis at a 20:1 NK:K562 ratio | Yes |
| Other3 | Flow cytometry | > 70% viable | Yes |
| Viability |
USP, The United States Pharmacopeial Convention; CFR , Code of Federal Regulations; LAL, Limulus Amebocyte Lysate; PTS, Prtable testing system.
1
Final product cells in cryopreservation medium.
2
Supernatant from end of culture cells.
3
End of production cells.