Quality Assessment of the Live Plague Vaccine Prepared Using nutrient Medium on the Basis of Hydrolysate of Concentrated Corn steep

Abstract

Objectiveof the study was to test the nutrient medium based on the enzymatic hydrolysate of corn extract condensed for a scaled production of live plague vaccine and to check the quality of the obtained batches against the specified parameters.Materials and methods.A dense nutrient medium based on corn extract was used to grow biomass in the process of live plague vaccine production. The quality parameters of the vaccine preparation obtained were studied by the regulated methods set forth in the regulatory documentation.Results and conclusions. The vaccine was monitored at all stages of its manufacture, including control of the finished dosage form, in strict accordance with the approved regulatory documentation. All the experimental production series complied with the specified indices. Approbation of the production cycle environment for live plague vaccine manufacturing showed efficiency of the conditions and the possibility of environment’s application in the industrial production of the preparation.