Table 4 Cell culture performance comparison between fed-batch Process C and Process A or B for different mAb production on Day 14 unless otherwise specified
Product | Process at bioreactor scale | Titer (normalized weight/L) | Peak VCD (× 106 cells/mL) | Cell specific productivity (normalized weight/cell/day) | Volumetric productivity (normalized weight/L/day) |
|---|---|---|---|---|---|
mAb1 | B at 1000-L (n = 5) | 0.5 ± 0.03 | 24.0 ± 2.7 | 2.05 ± 0.20 | 0.035 ± 0.002 |
C at 500-L (n = 2) | 1.00 ± 0.02 | 29.7 ± 1.3 | 2.98 ± 0.06 | 0.071 ± 0.002 | |
mAb2 on Day 10 | B at 1000-L (n = 5) | 0.50 ± 0.02 | 19.5 ± 1.1 | 3.03 ± 0.21 | 0.042 ± 0.002 |
C at 5-L (n = 4) | 1.00 ± 0.01 | 33.4 ± 1.6 | 3.04 ± 0.07 | 0.084 ± 0.001 | |
mAb3 | B at 1000-L (n = 3) | 0.53 ± 0.02 | 22.3 ± 0.3 | 2.24 ± 0.05 | 0.034 ± 0.000 |
C at 500-L (n = 2) | 1.00 ± 0.05 | 40.9 ± 5.0 | 2.41 ± 0.36 | 0.071 ± 0.001 | |
mAb4 | A at 1000-L (n = 5) | 0.31 ± 0.03 | 32.9 ± 2.7 | 1.05 ± 0.14 | 0.022 ± 0.002 |
C at 5-L (n = 4) | 1.00 ± 0.02 | 42.3 ± 1.3 | 2.28 ± 0.08 | 0.071 ± 0.002 | |
C at 500-L on Day 12 (n = 1) | 1.00 | 47 | 2.24 | 0.083 |