Particle Count Analysis by Coulter Counter of mAb A Formulation upon Mixing in Three BMMs Using the Mixing Conditions Listed in Table IV
| Mixing Time (h) | Particle Count (particles/mL) | ||
|---|---|---|---|
| JetMixerTM | Mobius® Mixer | LevMixer® | |
| 0 | 5.79 × 103 | 2.86 × 103 | 4.50 × 103 |
| 1 | 5.39 × 104 | 5.82 × 103 | NT |
| 2 | 9.52 × 104 | 5.76 × 103 | NT |
| 3 | 1.79 × 105 | NT | NT |
| 4 | 2.31 × 105 | 5.36 × 103 | NT |
| 8 | NT | 5.97 × 103 | 7.20 × 103 |
| Change in SvP Relative to t = 0a | 40 | 2 | 2 |
BMM, bottom-mounted mixer; NT, not tested.
↵a Change in SvP relative to t = 0: average particle count after mixing for 4 h for JetMixerTM or 8 h for Mobius® Mixer and LevMixer® ÷ average particle count in mAb A at t = 0.