Escalado de Producción de la Vacuna Cubana Antitifoídica de Polisacárido Vi de Salmonella typhi.

Since 1995, in our Institute we have been working on a project to produce the typhoid Vi polysaccharide vaccine in Cuba. During the research stage we obtained all the operation and control parameters in the different steps of the process, in this way enabling its characterization and obtaining the necessary equations to define the operation and control parameters for industrial scaling-up. Similar geometrically and dynamically systems were guaranteed, thus achieving similar results for the research stage, as well as for the production one. Also, three consecutive batches of final vaccine (8001, 8002, 8003) were produced and they fulfilled the quality specifications established by the World Health Organization ( WHO ) for this product. [ABSTRACT FROM AUTHOR]