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