Table 2.
Formulation | Fill volume (vial size) | Target product temperature | Chamber pressure | Freezing temperature (ramp rate) | Primary drying | Secondary drying | ||
---|---|---|---|---|---|---|---|---|
Shelf temperature (ramp rate) | Drying Time | Shelf temperature (ramp rate) | Drying time | |||||
HES + disaccharide (i.e. Formulation A) | 1 mL (5 cc) | –40 °C | 70 mTorr | –45 °C (1 °C/min) | –20 °C (1.3 °C/min) | ~12 h | +33 °C (0.3 °C/min) | 2 h |
Samples with sorbitol in formulation B, C and D | 2 mL (5 cc) | –31 °C | 100 mTorr | –40 °C (1 °C/min) | –18 °C (0.2 °C/min) | ~43 h | +40 °C (0.1 °C/min) | 6 h |
Samples with glycerol in formulation B, C and D | 2 mL (5 cc) | –40 °C | 60 mTorr | –45 °C (1 °C/min) | –34 °C (0.2 °C/min) | ~88 h | +40 °C (0.1 °C/min) | 5 h |
HES 0.75% + trehalose:glycerol (i.e. Formulation E) | 5 mL (20 cc) | –40 °C | 70 mTorr | –45 °C (1 °C/min) | –34 °C (0.2 °C/min) | ~72 h | +40 °C (0.1 °C/min) | 6 h |