The work program to which the TRANSBIO project relates is SMEInst-05-2016-2017: Supporting innovative SMEs in the healthcare biotechnology sector”. This work programme topic in 2016 refers to “cell technologies in medical applications”. Cell technologies refer to all types of technologies involving cell manipulation and medical applications refer to all types of applications related with human health (diagnosis, disease management, drug development, etc.).
The TRANSBIO project proposes the use of cellular biotechnology (our assay implies manipulation and analysis of peripheral blood mononuclear cells, PBMCs, and cell surface markers like cytokines) in a medical application that is the clinical management of renal transplanted patients. Furthermore, the work programme topic underscores the importance of compliance with safety and regulatory requirements.
In line with this specific requirement of the work programme, in the TRANSBIO we plan to perform a clinical validation study as our most important objective, with final goal of getting the regulatory approval for product commercialization. Therefore, our project has been designed specifically to comply with regulation requirements. In all aspects analyzed, there is no doubt about the suitability of TRANSBIO to the work programme topic.