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. 2020 May 25;12(1):1763727. doi: 10.1080/19420862.2020.1763727

Table 1.

Process changes between Tox and FIH batches a.

Molecule Media Changes b Process Setpoint Changes
mAb-A
  • No

  • No

mAb-B
  • Basal

  • Feed

  • Inoculation density

  • Feed volume

  • Feeding Strategy

mAb-C
  • Basal

  • Inoculation density

  • pH setpoint

  • Feeding Strategy

mAb-D
  • No

  • No

mAb-E
  • Feed

  • Feeding Strategy

mAb-F
  • No

  • No

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.