Experimental Conditions for Determining Worst-Case Mixing Time and Assessing Worst-Case Mixing Impact on Drug Product Quality
| Mixer | Worst-case Mixing Time (dye in 55% w/w sucrose solution) | Mixing Impact on mAb A1 (with extended mixing time) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| At low speed | At high speed | ||||||||
| Mixing Speed (rpm) | Volume (L) | Mixing Time (min) | Mixing Speed (rpm) | Volume (L) | Mixing Time (min) | Mixing Speed (rpm) | Volume (L) | Mixing Time (min) | |
| Magnetic Mixer | 100 | 45 | <1 | 100 | 30 | 480 | 165 | 30 | 60 |
| LevMixer | 128 | 45 | <1 | 128 | 30 | 480 | 210 | 30 | 60 |
| Mobius Mixer (50 L) | 240 | 45 | 85 | 240 | 30 | 480 | N/A | N/A | N/A |
| Mobius Mixer (50 L) | 400 | 45 | 22 | N/A | N/A | N/A | 400 | 30 | 60 |
N/A, not applicable.