Table 1 Post-nebulized integrity analysis of a formulation containing PRS-220 at 45 mg/mL nebulized with an investigational eFlow® Nebulizer System
Test method | Test result | Comparability criteria | Pre-nebulization (n = 1) | Post-nebulization (n = 3) |
|---|---|---|---|---|
Subvisible particulate matter (light obscuration) | Cumulative particulates per mL >2 µm | <Factor 10 difference | 45 | 196 |
Cumulative particulates per mL >5 µm | 19 | 66 | ||
Cumulative particulates per mL >10 µm | 7 | 28 | ||
Cumulative particulates per mL >25 µm | 1 | 1 | ||
Turbidity | FTU (500–600 nm, blank subtracted) | ≤ 10.0 | 3.7 | 2.9 |
cIEF | Main peak [%] | ≥ 75.0 | 82.4 | 83.1 |
Acidic peaks [%] | - | 17.6 | 16.9 | |
Basic peaks [%] | - | Not detected | Not detected | |
SEC | Main peak [%] | ≥ 95.0 | 99.7 | 99.7 |
HMWS [%] | ≤ 5.0 | 0.3 | 0.3 | |
LMWS [%] | - | Not detected | Not detected | |
ECLA | Relative potency [%] | 80 – 120 | 105 | 100 |
