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 |