The Use of Lyophilization as a Technological Platform in the Preservation of a Vaccine of the National Immunization Program

Abstract

Facing the importance of knowing the correlation between the controllable variables of a lyophilization and their impact on quality parameters established by regulatory agencies of health products the correlation between the freezing rate and the speed of sublimation achieved during the lyophilization of an immunobiological product. For this, performed in which the lyophilization parameters have been set, the temperature and pressure cycles were identical, with the exception of the two freezing rates which in the first experiment (batch A) was −0.22 °C/min and second experiment (batch B) was −1.77 °C/min. For these experiments, the mass reduction velocity was measure during the sublimation step in the lyophilization process. 1. The effects of freezing stability of the proteins vary significantly. 2. The immunobiological product evaluated was sensitive to the two freezing rates applied. With the control of parameters of the lyophilization process, in particular nucleation, is reduce the drying time and consequently the process. 3. The freezing rate of −0.22 °C/min can be used as a freezing rate appropriate to the lyophilization process of the immunobiological product studied since this condition optimized the mass reduction time during the sublimation stage and above all preserved the requirements of the final product quality. 4. With this, it becomes possible to rationalize the costs of inputs and energy related to the production of this immunobiological, as well as conscious maintenance of natural and ecological resources available for this purpose.