Freeze-drying design and process amplification of the new formulation of swine fever vaccine.

To screen the thermostable and safe freeze-drying procedure of swine fever vaccine, the magnification of lyophilization was explored to provide theoretical basis and technical support for heat-resistant freeze-drying process from laboratory to production. The freeze-drying procedures were designed based on the thermal parameters, and screened through the freezing shape, accelerated aging experiment, residual water and other indicators. The results showed that the eutectic point of the new swine fever-resistant live vaccine solution was-26.4 ℃, the collapse temperature-22.4 to-20.4 ℃, and the freeze-drying procedure 3 was screened as the optimal curve when the prefreeze temperature was-42 ℃ and the main drying temperature was-10 ℃. This study successfully screened the optimal freeze-drying process 3 was adequate for 0.5 m~2 freeze-dryer, and the temperatures of pre-freezing and primary drying were-42 ℃ and-10 ℃, respectively. The procedure 3 in 0.15 m~2—0.5 m~2—2 m~2 enlarged the process of the process groping, scaled up 3 times(0.5 m~2) when the program could remain unchanged, zoomed in to 13 times(2 m~2) under the main drying phase which needed reducing the partition temperature and extending the drying time. Frozen live vaccine products prepared with a new swine fever-resistant formula and program 3 could be saved at 37 ℃ for 20 d, 45 ℃ for 14 d, and animal experiments were safe. These results showed that the freeze-drying process of the new heat-resistant formulation was successfully screened out, and the process was enlarged step by step.