Technical transfer and commercialisation of lyophilised biopharmaceuticals — application of lyophiliser characterisation and comparability

AAPS Open

Table 2 Freeze-drying recipe used for Kv determination at different pressure set points (SP)

Step	Shelf temp (°C)	Chamber pressure (µbar)	Step time (HH:MM)
1. Loading	5	N/A	N/A
2. Freezing ramp	−40	N/A	2:00
3. Freezing hold	−40	N/A	4:00
4. Evacuation	−40	SP1-SP3 (Table 3)	N/A
5. Sublimation ramp	0	SP1-SP3 (Table 3)	1:10
6. Sublimation hold	0	SP1-SP3 (Table 3)	SP1-SP3 (Table 3)