A research biobank is a facility that collects, stores and manages biological material and related clinical data in an organized manner for research purposes. Biological material is an essential asset for the progress of biotechnology, an emerging sector on a world scale, which, according to OECD estimates, will have a huge weight on the world economy in 2030 and will account for 2.7% of global GDP overall.
Research biobanks have a wide impact and those who use deposited materials require guarantees regarding the collection, transport, storage, traceability and distribution of these materials. For the progress of research, it is therefore essential that the biological materials deposited are of quality, and that they are managed by the biobanks in order to ensure the reproducibility and comparability of the research results, through standard processes and procedures.
These needs are met by the accreditation of biobanks according to UNI ISO 20387:2019 “Biotechnologies – “Biobanking” – General requirements for biobanking”, specifying the general requirements of competence, impartiality and consistent functioning of the structures. The standard defines a broad framework of reference shared internationally for the collection, storage and subsequent use of samples, and represents the reference for requesting and obtaining accreditation.
On 14 July, the first Italian Biobank – the Multi-specialistic Biobank of the Pisan University Hospital – obtained accreditation in compliance with UNI ISO 20387. The assessment process involved an assessment team with expertise in both biobanking and biological material of human origin, in the field of quality management systems, IT and information security, privacy and GDPR. The assessment was carried out on a documentary level and through on-site verification. It is the first Italian biobank to obtain this very important recognition.
The accreditation scheme and related regulations were developed by the Calibration Laboratories Department of Accredia, in collaboration with the National Institute of Health in Italy (ISS – Istituto Superiore di Sanità) and the Testing Laboratories Department of Accredia. The support of a Technical Consultation Table specifically set up and composed of the main institutions involved is also fundamental: Ministry of Health, Ministry of Agricultural, Food and Forestry Policies, National Institute of Health in Italy, Association of Zooprophylactic Institutes, Council for Research in Agriculture and analysis of the agricultural economy, BBMRI – Italy, National Institute of Metrological Research, JOINT RESEARCH UNIT MIRRI-IT, National Order of Biologists, RIBES.
A result achieved thanks to the collaboration between Accredia and the Ministry of Health with the launch of a Pilot Project which in 2021 involved three Biobanks belonging to three Scientific Institutes for Research, Hospitalization and Healthcare (IRCSS) in the preliminary assessments in compliance with the standard UNI ISO 20387.
Accreditation provides a clear and reliable index of the capabilities and adequacy of the structure in terms of competence, impartiality and consistent functioning, in line with the international standard. Furthermore, the assessment process preparatory to the issue of the accreditation certificate provides valuable information to support the Biobank in the fundamental process of simplifying the procedures, favoring a potential saving of time and money.
As for the results, accreditation increases confidence in the production of the biobank and ensures that interested parties comply with the crucial requirements, contributing to the progress of scientific research in the sector.