Table 6.
Excipients | Fr 3 | Fr 4 | Fr 5 | Fr 6 | Fr 7 |
---|---|---|---|---|---|
Trehalose ( %,w/v) | 30 | 30 | 30 | 30 | 30 |
Gelatin (%,w/v) | 5 | 5 | 5 | 5 | |
Methionine (%,w/v) | 2 | ||||
DMSO (wt %) | 0.5 | ||||
Pluronic F68 (wt %) | 0.02 | ||||
Potassium phosphate (mM) | 25 | 25 | 25 | 25 | 25 |
pH | 8 | 8 | 8 | 8 | 8 |
Process loss (log10 CFU) | 1.0 ± 0.2 | 1.0 ± 0.7 | 0.7 ± 0.5 | 0.7 ± 0.3 | 1.0 ± 0.2 |
Residual Water (%) | 5.2 ± 0.1 | 2.5 ± 0.1 | 1.2 ± 0.1 | 1.2 ± 0.3 | 2.6 ± 0.3 |
Tg (°C) | 57.6 ± 1.3 | 99.4 ± 2.2 | 103.5 ± 1.6 | 103.3 ± 2.8 | 90.9 ± 1.4 |