Standardization and reproducibility in EV research: the support of a Quality management system. Biological membrane vesicles: scientific, biotechnological and clinical considerations

Scientific research is becoming increasingly competitive, requiring researchers to continuously improve and enhance their performance, and technologically complex, raising issues as reliability and reproducibility of the data as well as standardization of the methodologies. Moreover, globalization and emergence of new markets had a great impact on funding agencies, that encouraged scientists to develop visionary ideas and outstanding technologies to respond to the needs of society. The study of extracellular vesicles (EVs) is emerging as an extremely promising field for biomedical, nutraceutical and cosmetic applications, and the scientific community working on EVs is facing key challenges to realize the EV promise. The implementation of Quality Management (QM) tools can be extremely valid for scientists to successfully overcome these challenges. It is fundamental, however, that QM is customized on the requirements, needs, expectations and resources of investigators, to be really helpful in research project and activities. In this chapter, we introduce the history, principles and standards of QM and show some examples of its implementation in the context of public research institutions. Then, we focus on key features and main challenges of the EV research, including the standardization of procedures and technologies to guarantee reliability and reproducibility of the data. Finally, we present the QM approach developed for the VES4US research project, whose objective is to realize a radical new platform for production, isolation and functionalization of EVs from a natural source. The tools utilized and the models developed can be incorporated in a roadmap for the effective and efficient scientific management of innovative and multidisciplinary projects, specially focusing on EVs.