Caja de Herramientas para la Conformación de un Biobanco a partir de los Lineamientos de la ISO 20387 en un Centro de Investigación en Salud De Colombia

Abstract

Although at an international level the use and maintenance of biobanks is a resource that has already been scientifically explored and proven, in Colombia it has not yet been cataloged in such a way, nor has its formation and recognition been necessary at both an investigative and clinical level; This possibly happens due to the lack of availability and access to such biological samples, making their exploration and use unconventional and limited, generating barriers to innovation in cellular therapies and regenerative medicine for the country.

During the systematic review carried out, it is evident that in Colombia there is no support platform (biobank) for the collection of biological samples conceived for diagnostic or biomedical research purposes that is under strict control from processing, storage and transfer between groups of research, under the guidelines of regulations that regulate its operation and guarantee compliance with processes with high quality standards. As demonstrated by the Congress of the Republic in 2023, the law that barely formalizes the creation of the National Biobank System, as well as its technological and biomedical research, where (Consultor Salud 2023) mentions that “The mechanisms will also be regulated. obtaining, using, processing, storing, transporting and transferring human biological samples, their derivatives and samples related to human health; clinical and biological information within the framework of dignity and human rights.”

It is very important to promote the construction of support platforms for the collection of biological samples that guarantee the correct processing, storage and exchange of biological material that provides innovative knowledge in the biomedical field and generates multiple advances in cell therapy and regenerative medicine for collective benefit.

Consequently, the research carried out in the health research center in Colombia showed that there is no formal biobank structure based on the ISO 20387 standard and, furthermore, in the country there is no platform or biobank that operates under the guidelines. of the standard in question; which leads to the need to propose a starting point for all those research institutions that seek to form collection, storage and transfer centers for biological material, which directly support structures aimed at development, technology, innovation and research. in health.