Table 3.
Final COA
| Test | Method | Requirement |
|---|---|---|
| Identity | ||
| Recipient identity | Visual inspection | Recipient study ID and recipient medical record number on this COA and on each infusion bag label identical to that in the production batch record, section 12.3 |
| Islet identity | DTZ stain and microscopic examination | Islets present in each product bag |
| Volumes in bags | ||
| Suspension volume | Direct measurement | 200 mL per product bag ≤600 mL total in three product bags |
| Settled tissue volume | Direct measurement after 5-min settling | ≤7.5 mL per product bag ≤15.0 mL total in three product bags |
| Potency | ||
| GSIR (high-purity islets, preculture sample) | ELISA | For information only, report stimulation index |
| GSIR (high-purity islets, postculture sample) | ELISA | Stimulation index >1 |
| Islet quantity | DTZ stain and microscopic examination | First infusion: ≥5.0 × 103 IEQ/kg recipient BW (total IEQ/ infusion) Subsequent infusions: ≥4.0 × 103 IEQ/kg recipient BW (total IEQ/infusion) |
| Viability | FDA/PI stain and microscopic examination | ≥70% in each product bag |
| Purity | ||
| Islet concentration | DTZ stain and microscopic examination | ≥20,000 total IEQ/mL total settled tissue volume |
| Safety | ||
| Appearance | Visual inspection | Light yellow to amber liquid with visible aggregates in each product bag |
| Endotoxins | LAL | ≤5.0 EU/kg of recipient BW (total EU/infusion) |
| Sterility | 21 CFR 610.12 | No growth in each product bag |
CFR, Code of Federal Regulations; EU, endotoxin unit; LAL, limulus amoebocyte lysate.