Table 1 Nanoparticle tracking assessment of BSA-DF and freeze dried/reconstituted BSA-DF nanoparticles from multiple fabrication lots (3).
Mean diameter (nm) | D10 (nm) | D50 (nm) | D90 (nm) | Span | |
|---|---|---|---|---|---|
Pre-lyophilized BSA-DF nanoparticles | |||||
Mean ± SD | 93 ± 1 | 71 ± 1 | 84 ± 2 | 108 ± 1 | 0.44 ± 0.03 |
COV (%) | 1.1 | 1.4 | 2.4 | 1.0 | 6.8 |
Reconstituted BSA-DF nanoparticles | |||||
Mean ± SD | 109 ± 1 | 81 ± 4 | 94 ± 2 | 143 ± 5 | 0.66 ± 0.03 |
COV (%) | 1.0 | 4.8 | 2.1 | 3.5 | 4.5 |