Table 4.
Characteristics of solutions of two monoclonal antibodies (IgG1 and IgG4) in different buffers with various concentrations of polysorbate, before and after nebulization. Each result is the mean (± SD) of three nebulizations
| DLS (% of monomer ± SD) |
Large antibody aggregates (103/ml ± SD) |
||||||
|---|---|---|---|---|---|---|---|
| Nebulizer | Type of surfactant | Surfactant concentration (% w/v) | Before nebulization | After nebulization | Before nebulization | After nebulization | |
| Mab 1 – Buffer 1* | Aerogen solo | PS-20 | 0 | 99.6 | 99.1 | 85.6 | 128.8 |
| 0.01 | 99.2 | 98.6 | 27.9 | 45.9 | |||
| 0.1 | 99.9 | 100 | 33.3 | 29.7 | |||
| Mab 2 – Buffer 2** | PARI eFlow | None | 0 | 100 | NA | 918.0 | NA |
| PS-20 | 0.01 | 100 | 97.3 ± 3.8 | 607.5 | 1024.7 ± 356.4 | ||
| 0.1 | 100 | 99.6 ± 0.3 | 783.0 | 625.5 ± 232.4 | |||
| PS-80 | 0.01 | 100 | 99.4 ± 0.4 | 388.8 | 954.0 ± 623.5 | ||
| 0.1 | 100 | 99.9 ± 0.0 | 702.0 | 688.5 ± 269.0 | |||
*
n = 1 nebulization; **n = 3 nebulizations; NA, not analyzable.