Table 2 Stability testing results for three sequential lots of kits for the preparation of 111In[In]-BnDTPA-trastuzumab-NLS injection
Parameter | Specification | 17N014 | 17N026 | 18N008 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
9 d a | 93 d | 127 d | 661 d | 21 d | 97 d | 139 d | 589 d | 16 d | 94 d | 129 d | 304 d | ||
Protein concentration | 4.5–5.5 mg/mL | 5.3 | n.d | 5.4 | 5.6 b | 5.4 | n.d | 5.5 | 5.6 b | 5.4 | n.d | 5.6 b | 5.9 b |
pH | 5.5–6.0 | 6.0 | 6.0 | 6.0 | 6.0 | 6.0 | 6.0 | 6.0 | 6.0 | 6.0 | 6.0 | 6.0 | 6.0 |
Appearance | Clear pale yellow, particle-free | Passed | Passed | Passed | Passed | Passed | Passed | Passed | Passed | Passed | Passed | Passed | Passed |
Purity and homogeneity | SDS-PAGE: 1 major band (170 kDa) under non-reducing conditions; 2 major bands (50 kDa and 25 kDa) under reducing conditions SE-HPLC: 1 major peak at tR = 11.7 ± 0.2 min | Passed | n.d. c | Passed | Passed | Passed | n.d | Passed | Passed | Passed | n.d | Passed | Passed |
111In Labeling efficiency | ITLC: ≥ 90% | 99.0 | 98.5 | 98.3 | 97.4 | 98.4 | 98.5 | 98.8 | 97.6 | 98.6 | 98.8 | 98.9 | 98.1 |
HER2 binding properties | SK-BR-3 cells: Ka = 1.0–8.0 × 108 L/mole; Bmax = 0.5–2.0 × 108 binding sites/cell | Passed | n.d | Passed | Passed | Passed | n.d | Passed | Passed | Passed | n.d | Passed | Passed |