Spray-Drying Formulations of mAb A and mAb B
| Formulation | Concentration (mg/mL) | Osmolality (mOsmol/kg) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| mAb | Na Phosphate Buffer | HisHCl Buffer | Na Citrate Buffer | Trehalose | mAb:Trehalose (molar ratio) | Arginine Succinate | NaCl | Total Solid | Average | |
| mAb A | ||||||||||
| A-1 | 25 | 6.29 | - | - | 54 | 0.5 (1:947) | 0 | 0 | 86 | 280 |
| A-2 | 109 | 6.29 | - | - | 54 | 2 (1:217) | 0 | 0 | 170 | 304 |
| A-3 | 109 | 5.59 | - | - | 209 | 0.5 (1:841) | 0 | 0 | 323 | 1245 |
| A-4 | 98 | - | - | - | 0 | NA | 43.5 | 0 | 142 | 206 |
| A-5 | 100 | - | - | - | 8.6 | 12 (1:38) | 43.5 | 0 | 152 | 233 |
| A-6 | 100 | - | - | - | 34.3 | 3 (1:150) | 43.5 | 0 | 178 | 325 |
| mAb B | ||||||||||
| B-1 | 25 | - | 0.87 | - | 20 | 1 (1:350) | 0 | 0 | 46 | 87 |
| B-2 | 104 | - | 0.84 | - | 48 | 2 (1:202) | 0 | 0 | 153 | 200 |
| B-3 | 117 | - | 0.77 | - | 220 | 0.5 (1:825) | 0 | 0 | 338 | 1153 |
| B-4 | 99 | - | - | - | 0 | NA | 43.5 | 0 | 143 | 196 |
| B-5 | 100 | - | - | - | 8.6 | 0.5 (1:37) | 43.5 | 0 | 153 | 211 |
| B-6 | 93 | - | - | - | 34.3 | 3 (1:162) | 43.5 | 0 | 171 | 299 |