Characterization of mAb Formulations (mAb A1 and mAb A2) Stressed in Different Stress Models
| Stress Model (Conditions) | Formulation | Turbidity (mAu) | SvP Analysis by MFI | Size Variants by SE-HPLC | ||||
|---|---|---|---|---|---|---|---|---|
| Particle Count (particles /mL) | Mean Particle size (μm) | Particle Count Ratio (Stressed vs. Control) | HMWs | Monomer | LMWs | |||
| Control (unstressed) | mAb A1 | 0.119 | 6.01 × 103 | 2.21 | NA | 1.3 | 98.5 | 0.1 |
| mAb A2 | 0.107 | 9.16 × 103 | 2.7 | NA | 1.3 | 98.6 | 0.1 | |
| Mavag mixing (bladeless impeller with inner reservoir; 200 rpm, 60 min) | mAb A1 | Too High | 6.07 × 107 | 2.28 | 10,090 | 1.3 | 98.5 | 0.2 |
| mAb A2 | Too High | 6.26 × 107 | 2.22 | 6,832 | 1.3 | 98.5 | 0.2 | |
| Rotor-stator homogenizing (5000 rpm, 60 min) | mAb A1 | 0.544 | 4.03 × 106 | 1.52 | 670 | 1.4 | 98.5 | 0.1 |
| mAb A2 | 1.311 | 1.32 × 107 | 3.31 | 1,445 | 1.4 | 98.5 | 0.1 | |
| Sonicating (50% amplitude, 60 min) | mAb A1 | 1.235 | 1.66 × 107 | 2.69 | 2,755 | 5.8 | 91.2 | 3 |
| mAb A2 | 0.488 | 8.09 × 106 | 2.24 | 883 | 4.1 | 93.6 | 2.3 | |