. 2010 Nov 6;11(4):1580–1590. doi: 10.1208/s12249-010-9530-9

Table II.

Product Temperature, Sublimation Rates, and Time Taken to Complete Primary Drying for the Three Model Proteins at 5 mg/mL in the Conservative and Aggressive Cycles

Protein	T _pr (TC)^a	T _pr (TC)^a	T _pr (T _bMTM)^a	T _pr (T _bMTM)^a	dm/dt ^a	dm/dt ^a	Time to complete PD	Time to complete PD
Protein	T _s = −25°C	T _s = +25°C	T _s = −25°C	T _s = +25°C	T _s = −25°C	T _s = +25°C	T _s = −25°C	T _s = +25°C
0 mg/mL (placebo)	−37.5	−32.4	−38.1	−33.4	0.040	0.17	22.5 (TC)	8.6 (TC)
0 mg/mL (placebo)	−37.5	−32.4	−38.1	−33.4	0.040	0.17	27.4 (PG)	10.2 (PG)
5 mg/mL Lysozyme	−35.7	−31.03	−36.3	−31.1	0.038	0.17	25.6 (TC)	9.5 (TC)
5 mg/mL Lysozyme	−35.7	−31.03	−36.3	−31.1	0.038	0.17	32.3 (PG)	9.8 (PG)
5 mg/mL BSA	−35.9	−30.5	−36.5	−30.7	0.036	0.16	26.2 (TC)	9.8 (TC)
5 mg/mL BSA	−35.9	−30.5	−36.5	−30.7	0.036	0.16	29.9 (PG)	9.9 (PG)
5 mg/mL IgG	−37.1	−29.9	−37.5	−30.5	0.033	0.15	27.9 (TC)	9.6 (TC)
5 mg/mL IgG	−37.1	−29.9	−37.5	−30.5	0.033	0.15	29.0 (PG)	9.2 (PG)

Runs were carried out in the AutoMTM mode, in Lyostar II, and all formulations are in 6 mM phosphate buffer containing 25 mg/mL sucrose. Shelf temperatures during PD were maintained constant at −25°C and +25°C. The time to complete primary drying (in hours) was determined both by average TC data placed bottom center in the center of the batch as well as PG data. Measured T _cmicro values for 5 mg/mL lysozyme, BSA, and IgG are −31.5°C, −31°C, and −32°C, respectively

T _s shelf inlet temperature, dm/dt sublimation rate (g/h per vial), T _bMTM product temperature at the vial bottom (°C), T _pr product temperature (°C), TC thermocouple, PD primary drying

^aAverage value obtained during steady-state primary drying but limited to the region where MTM data are valid