Radiolabeling and Quality Control Results for 89Zr-DFO-N-Suc-Cetuximab and 89Zr-DFO-N-Suc-Rituximab Produced on GRP 2V synthesis Module Starting from 60 MBq of 89Zr (n = 3)
| Reaction detail | 89Zr-DFO-N-suc-cetuximab | 89Zr-DFO-N-suc-rituximab |
| Start activity (MBq) | 63.55 ± 2.13 | 63.01 ± 5.12 |
| Radiochemical yield by iTLC (%) | 92.0 ± 1.2 | 95.2 ± 0.2 |
| Isolated product (MBq) | 47.41 ± 2.88 | 39.56 ± 5.03 |
| Labeling yield (non–decay-corrected) (%) | 74.6 ± 2.0 | 62.6 ± 3.0 |
| Quality control of isolated product | ||
| Radiochemical purity by iTLC (%) | 98.3 ± 0.4 | 99.1 ± 0.1 |
| Radiochemical purity by SEC-HPLC (%) | 99.5 ± 0.3 | 100 ± 0 |
| Protein integrity by SEC-HPLC (%) at 280 nm | 100 ± 0 | 100 ± 0 |
| Immunoreactivity by Lindmo assay (%) | 95.9 ± 0.6 | 87.1 ± 2.2 |
| Sample value bacterial endotoxin content assay (<2.5 endotoxin units/mL) | 0.226 ± 0.045 | 0.301 ± 0.175 |
Data on individual labeling are provided in supplemental materials.