Table 6: CMO transfer-related activities.
| Activity | Organization |
|---|---|
| Transfer radiolabeled synthetic methods | Takeda |
| Transfer analytical methods | Takeda/CMO |
| Test synthetic methods by unlabeled and labeled compounds | CMO |
| Technical batch API synthesis | CMO |
| GMP synthesis of radiolabeled API | CMO |
| QC data | CMO |
| Generation of batch records | CMO |
| Review of batch records and analytical data | Takeda |
| Prepare stability protocol and analyze samples | Takeda/CMO |
| Approve and release the radiolabeled API for clinical use | Takeda |