Establishment of an operational model for a mesenchymal stem cell and exosome cryopreservation unit as a platform for promoting research in Costa Rica: Phase 1

The project is structured in three phases. The first phase focuses on the design of the functional prototype of the Cryopreservation Unit, including the operating model, workflows, biosafety, technical requirements, and standardized operational procedures (SOPs) for the handling of stem cells and exosomes. It then focuses on the collection, isolation, and validation of mesenchymal stem cells and exosomes, following the ISSCR and MISEV international guidelines, through the analysis of phenotypic markers, viability, and structural characterization by DLS and electron microscopy. Finally, a hydrogel previously formulated to incorporate exosomes will be developed, conceived as a biotechnology product model and stabilizing vehicle, evaluating its physicochemical stability. The project is structured in three phases. The first phase focuses on the design of the functional prototype of the Cryopreservation Unit, including the operating model, workflows, biosafety, technical requirements, and standardized procedures (SPOs) for the handling of stem cells and exosomes. It then focuses on the collection, isolation, and validation of mesenchymal stem cells and exosomes, following the ISSCR and MISEV international guidelines, through the analysis of phenotypic markers, viability, and structural characterization by DLS and electron microscopy. Finally, a hydrogel previously formulated to incorporate exosomes will be developed, conceived as a biotechnology product model and stabilizing vehicle, evaluating its physicochemical stability. The project does not contemplate therapeutic application in humans, limiting itself to the use of discarded human tissue strictly for in vitro biomedical research purposes. The final products will include the design of the Cryopreservation Unit prototype, followed by validated batches of characterized mesenchymal stem cells and exosomes, and the formulation of the hydrogel as a vehicle and stabilizer for the exosomes. The project is progressing from TRL 3 (laboratory proof of concept) to TRL 4 (validated prototype in a laboratory), according to the European Union's classification for technological developments. This approach integrates applied research, technological development, and innovation, contributing to the strengthening of national capacities in advanced therapies, regenerative medicine, and high value-added bioproducts. The project is directly aligned with ODS 3 (Good Health and Well-being), ODS 9 (Industry, Innovation and Infrastructure), and ODS 12 (Responsible Consumption and Production), as well as with the institutional policy on innovation and bioeconomy of the Technological Institute of Costa Rica.

Implementar un modelo operativo de una Unidad de Criopreservación para la producción estandarizada de productos biológicos a partir de células madre mesenquimales y exosomas, destinados a investigaciones científicas.

Aplicaciones Biomédica