Biomanufacturing of vaccines / A narrative review
Palabras clave:
Vaccine, Upstream, Downstream, Biomanufacturing, Biomanufacturing plantResumen
Background. The manufacture of vaccines is a process that is supervised and continuously evaluated by regulatory authorities through compliance with good manufacturing practices, to support their safety and efficacy, and to ensure that they can be used in humans, which must meet high quality standards, both at the level of the active substance and the finished product. Likewise, the plants where all manufacturing processes are carried out must comply with the requirements of Good Manufacturing Practices (GMP), according to the World Health Organization (WHO).
Objectives. To understand the processes of manufacture of antigenic substances according to the types of vaccines and to describe the characteristics of the facilities of a vaccine biomanufacturing plant. Method. The methodology used for the review was a search for scientific articles and literature in the search engines PubMed, Cochrane, Google Scholar and Preprints, focused on vaccine Biomanufacturing.
Discussion. The World Health Organization (WHO) and medicines regulatory agencies establish a series of standards or instructions for obtaining antigens for vaccines in the different platforms, as well as for the plants where the final manufacture is carried out, in addition to the formulation and quality control components necessary to provide safe and effective vaccines to patients.
Conclusions. Vaccine biomanufacturing is a process of utmost importance for public health systems, since immunization saves many lives around the world, reduces the cost of care for current and emerging diseases, and contributes to the fight against antimicrobial resistance.
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