Table 7 Batch analysis for 4 validation batches of [68Ga]Ga-ABY-025
From: Optimized, automated and cGMP-compliant synthesis of the HER2 targeting [68Ga]Ga-ABY-025 tracer
Test attributes | Product Specification | Batch 1 | Batch 2 | Batch 3 | Batch 4 | Statistical data (n = 4) |
|---|---|---|---|---|---|---|
Activity EOS (after withdrawal of QC- and sterility samples) | ≥ 300 MBq | 363 MBq | 385 MBq | 380 MBq | 392 MBq | 380 ± 12 MBq |
Volume (after withdrawal of QC- and sterility samples) | ≤ 10 mL | 7.8 mL | 8.0 mL | 8.0 mL | 8.8 mL1 | 8.2 ± 0.4 mL |
Activity concentration | ≥ 30 MBq/mL | 47 MBq/mL | 48 MBq/mL | 48 MBq/mL | 45 MBq/mL | 47 ± 1 MBq/mL |
Radiochemical yield (decay-corrected)2 | N/A | 41% | 46% | 43% | 46% | 44 ± 2% |
Appearance | Clear and/or slightly yellow. Free of visible particles | Complies | Complies | Complies | Complies | Complies |
pH | 4.0–8.0 | 5.0 | 5.0 | 5.0 | 5.0 | 5.0 ± 0.0 |
Product identity [68Ga]Ga-ABY-025 | |RtRD − RtUV|≤ 60 s | 11 s | 7 s | 12 s | 13 s | 11 ± 3 s |
Concentration of ABY-025 (principal peak on UV) | 40–60 µg/mL | 50 µg/mL | 50 µg/mL | 60 µg/mL | 60 µg/mL | 55 ± 6 µg/mL |
Chemical impurity (peaks except principal peak on UV) | ≤ 10 µg/mL | < 4 µg/mL | < 4 µg/mL | < 4 µg/mL | < 4 µg/mL | < 4 µg/mL |
Radiochemical impurity [68Ga]-ions and/or unidentified radioactive impurities = B | ≤ 3% | 1% | 0% | 1% | 2% | 1 ± 1% |
Total radiochemical purity[68Ga]Ga-ABY-025 RCPTot = (100 − B) × T | ≥ 91% | 99% | 98% | 98% | 98% | 98 ± 1% |
Filter integrity3 | ≥ 3.5 bar | 4.3 | 4.1 | 4.2 | N/A | 4.2 ± 0.1 bar |
Bacterial endotoxins | < 17.5 IU/mL | < 5 IU/mL | < 5 IU/mL | < 5 IU/mL | < 5 IU/mL | < 5 IU/mL |
Ethanol content | < 80 mg/mL | 45 mg/mL | 45 mg/mL | 48 mg/mL | 44 mg/mL | 46 ± 2 mg/mL |
Sterility | Sterile, 0 CFU | Sterile | Sterile | Sterile | Sterile | Sterile |
Radionuclidic identity Half-life 68Ga | 62–74 min | 67 min | 69 min | 67 min | 69 min | 68 ± 1 min |
Radiochemical stability 2 h EOS | RCPTot ≥ 91% | 98% | 98% | 98% | 97% | 98 ± 1% |