Table 1.
Process changes between Tox and FIH batches a.
Molecule | Media Changes b | Process Setpoint Changes |
---|---|---|
mAb-A |
|
|
mAb-B |
|
|
mAb-C |
|
|
mAb-D |
|
|
mAb-E |
|
|
mAb-F |
|
|
a. Process changes were for productivity and/or quality considerations.
b. Media changes were limited to implementation of different versions of BMS platform media, in which main components were the same.