Hold-up Volumes (VHU) of Various Drug Product Presentations, in Vial and Withdrawal Syringe. The Average and Standard Deviation VHU Values Are Reported. Vial Format and Number of Measurements (n) Are Provided in Parentheses
| Vial Neck Diameter (mm) | Viscosity at 20°C (η, mPa. s) | Drug Product | Hold-up Volume (VHU, µL) |
|---|---|---|---|
| 13 | 1.0 | Peptide | 158 ± 21 (2R, n = 45) |
| 1.8 | IgG4#1 | 167 ± 30 (2R, n = 40) | |
| 2.2 | TsAb#1 | 164 ± 6 (2R, n = 2) | |
| 2.5 | IgG4#2 | 125 ± 40 (2R, n = 15) | |
| 3.4 | IgG4#5 | 159 ± 51 (2R, n = 47) | |
| 6.2 | TsAb#2 | 216 ± 29 (2R, n = 6) | |
| 12.1 | BsAb | 239 ± 39 (2R, n = 30) | |
| 16.6 | IgG4#6 | 166 ± 47 (2R, n = 10) | |
| 20 | 1.0 | SMD#1 | 195 ± 58 (6R, n = 34) |
| SMD#2 | 220 ± 83 (6R, n = 141) | ||
| SMD#3 | 317 ± 36 (20R, n = 103) | ||
| IgG1 | 155 ± 34 (20R, n = 34) | ||
| 1.8 | IgG4#1 | 186 ± 24 (6R, n = 10) | |
| 2.5 | IgG4#2 | 273 ± 76 (20R, n = 8) | |
| IgG4#3 | 350 ± 98 (20R, n = 15) | ||
| 2.6 | IgG4#4 | 186 ± 46 (6R, n = 15) | |
| 299 ± 80 (20R, n = 21) | |||
| 3.0 | sdAb | 310 ± 42 (20R, n = 5) | |
| 3.4 | IgG4#5 | 307 ± 44 (6R, n = 18) | |
| 16.6 | IgG4#6 | 313 ± 54 (6R, n = 132) | |
| 323 ± 29 (10R, n = 28) | |||
| 19.9 | Fab'-PEG | 451 ± 70 (10R, n = 12) |
BsAb, bispecific antibody; Fab'-PEG, pegylated antigen-binding fragment; IgG, immunoglobulin; sdAb, single-domain antibody; SMD, small molecule drug; TsAb, trispecific antibody.