Proceso de elaboración de una vacuna a partir de un principio activo sólido termolábil

Abstract

Influenza A H1N1 is a viral disease that affects the airways, and causes death in approximately 10% of people who suffer from it. To counteract this disease, various laboratories developed different vaccines. Vaccines are generally pharmaceutical preparations in suspension form, used to activate immunity, they do not cure a disease, but rather serve to prevent the effects of future bacterial or viral infections, thus avoiding any fatal outcome. Vaccines require a complex manufacturing process, with different unit operations that are carried out in specialized equipment under strict conditions of good manufacturing practices. This work describes the process of elaboration of an injectable pharmaceutical form (vaccine) from inactivated surface antigens of the influenza virus H1N1 pdm 09, where the main unit operations and equipment that can be used during its treatment are detailed. manufacturing. Both the active ingredient and the auxiliary substances used in the preparation of the vaccine, as well as the finished product, must go through different quality controls to ensure their effectiveness, safety and efficacy.