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Critical Quality Attributes for optimized intermediate nanoGLA, diafiltrated and concentrated around 10-fold.
| Attributes | After DELOS-susp (Intermediate nanoGLA) | After concentration (Preclinical nanoGLA) |
|---|---|---|
| Stability | NA | >2 weeks |
| Particle mean size (nm) | 138 ± 7 | 165 ± 3 |
| Polydispersity Index | 0.38 ± 0.03 | 0.41 ± 0.02 |
| ζ-potential (mV) | 40 ± 1 | 35 ± 1 |
| Enzymatic activity (ratio to control) | 1.11 ± 0.08 | 0.93 ± 0.04 |
| GLA (µg/mL) | 34 ± 2 | 330 ± 20 |
