Particle Count Analysis by Coulter Counter of mAb A Solution after Mixing at 200 rpm for up to 1 h in a Mavag Mavadrive™ Mixer with Different Impeller Designs
| Particle Count (particle/mL)a | ||||
|---|---|---|---|---|
| Mixing Time (h) | Impeller with Blades (2.5 L of mAb A) | Impeller without Blades (2.5 L of mAb A) | Impeller without Blades but with Attached Plastic Cylinder Dividerb | |
| Outer Reservoir (2.5 L of mAb A) | Inner Reservoir (10 mL of mAb A)c | |||
| 0 | 2.55 × 104 ± 5.24 × 103 | 1.45 × 104 ± 4.08 × 103 | 1.24 × 104 ± 8.55 × 102 | 1.88 × 104 ± 1.01 × 104 |
| 0.5 | 1.74 × 105 ± 6.68 × 104 | 1.93 × 105 ± 1.46 × 104 | 1.94 × 104 ± 9.80 × 103 | 1.86 × 107 ± 2.28 × 106 |
| 1.0 | 4.67 × 105 ± 8.71 × 104 | 5.03 × 105 ± 2.77 × 104 | 1.29 × 104 ± 3.02 × 103 | 2.77 × 107 ± 5.29 × 106 d |
| Change in SvP Relative to t = 0e | 18 | 35 | 1 | 1471 |
↵a Particle count data represents an average of two separate trials.
↵b Particle count in the outer reservoir is an average of counts in samples taken from areas close to the impeller and away from the impeller.
↵c Particle count before volume correction. Particle count after volume correction can be measured by diluting a sample from the inner reservoir 250 times using the solution in the outer reservoir.
d The average particle count of the diluted material was determined to be 2.60 × 105 particles/mL.
↵e Change in SvP relative to t = 0: average particle count after mixing for 1 h ÷ average particle count in mAb A at t = 0.