Table 2. Quality control results of the three batches (ZR-PAN-MBR-01, ZR-PAN-MBR-02, and ZR-PAN-MBR-03) of 89Zr-panitumumab.
| Quality control test | Description | Acceptance criteria | ZR-PAN-MBR-01 | ZR-PAN-MBR-02 | ZR-PAN-MBR-03 |
|---|---|---|---|---|---|
| Particulates and color | Visual inspection for color and particulates | Clear and colorless | Clear and colorless | Clear and colorless | Clear and colorless |
| Filter Integrity | Bubble point test | ≥46 PSI | 58 | 57 | 60 |
| pH | pHas per USP<791> pH | pH must be between 6 and 8 | 7.0 | 7.0 | 7.0 |
| Radiochemical ID and purity(%) | Radio-TLC | Rf <0.5; purity ≥90% | >98 | >98 | >98 |
| Radiochemical identity | Half-life test | 74-82 h | 76.4 | 75.8 | 76.3 |
| Radiochemical purity | HPLCa, consistent with guidelines of USP <621> | Radiochemical purity ≥90% | 97 | 95 | 96 |
| Chemical purity | HPLCa, consistent with guidelines of USP <621> | Chemical purity ≤1 mg of panitumumab per dose | 0.38 | 0.42 | 0.40 |
| Specific activity | Expressed as MBq/mg of panitumumab | ≥1.5 mCi (55.5 MBq)/mg of panitumumab | 3.8(140.6) | 3.4 (125.8) | 3.5(129.5) |
| Bacterial endotoxin levels | Limulus Amebocyte Lysate (LAL) by PTS | <175 EU per dose | <2 | <2 | <2 |
| *Immunoreactivity | In vitro cell-binding assay | ≥60% | >60% | >60% | >60% |
| *Sterility test (14 days) | USP sterility test (USP <71>) | No growth | No growth | No growth | No growth |
a
HPLC column (Superdex 200 10/300 GL) with mobile phase flow rate of 0.8 mL/min
*
not a product releasing criterion