The international recognition of accredited biobanks represents a fundamental step towards establishing global trust in the competence of these structures. Recently, the second national accreditation was awarded to an important biobank, reflecting the growing commitment to the quality of biobanking services in Italy. The standardization of procedures and accreditation requirements has been further strengthened with the establishment of the EN ISO 20387 standard, recognized as the harmonized standard for the sector.
This standard, published in Italy with the designation UNI CEI EN ISO 20387:2024, establishes general requirements for biobanks, outlining criteria for competence and impartiality for facilities engaged in the collection, preservation, and management of biological material and associated clinical data for research and development purposes. The relevance of this sector is expected to grow: according to OECD estimates, biobanking is projected to account for 2.7% of global GDP by 2030, highlighting its potential economic impact.
In Europe, the recognition of the ISO 20387 standard as a harmonized standard is a key factor in promoting trust in these practices, not only locally but on a global scale. This process is essential for a highly international sector, where cooperation and standardization are vital. European accreditation bodies have begun compiling a list of accredited biobanks, and our country has already seen the issuance of accreditations for two facilities. These certifications not only ensure the quality of biobanks but also foster the development of research and biotechnology.
The credibility of the accreditation system is further supported by the new International Mutual Recognition Agreement, which will enable the mutual recognition of accredited biobanks among various European countries. This means that the materials and competencies of accredited biobanks will be considered equivalent across the European accreditation network. Agreements of this kind help to ensure the equivalence of accreditations, facilitating the circulation of certified goods and services in global markets.
In this context, the peer evaluation process among accreditation bodies serves as a guarantee of competence, procedural rigor, and uniformity of approach among the various institutions. The recent accreditation of an Italian biobank, the second to receive this recognition in the country, represents a further step forward in raising national standards in biobanking. This accreditation promotes an increasingly advanced research environment, contributing to the development of innovative technologies and robust scientific practices.
Ensuring the quality of biological samples is essential; this can only be achieved through traceable and compliant management of every phase, from acquisition to preservation, including transport and distribution. Biobanks must adopt standard procedures and maintain strict control over associated clinical data to ensure the comparability and reproducibility of research results.
Compliance with the ISO 20387 standard also provides accredited biobanks with the opportunity to demonstrate their operational capabilities and the validity of their structures, ensuring that they are adequately competent, impartial, and operationally consistent. The standard encompasses the entire process of managing biological material, including aspects such as the quality management system, a crucial element in ensuring credibility in scientific research.
Establishing the reliability of a biobank leads to tangible benefits, including a positive impact on public healthcare spending, thanks to the generation of more robust and informed research results. The increasing integration of biobanks into research processes enables the advancement of personalized medicine and facilitates the development of new drugs and therapeutic solutions.
The commitment to accreditation and adherence to international biobanking standards not only promotes a better research environment but also represents a guarantee for researchers and patients in a context where the reliability of data and the quality of biological resources are of vital importance. It is clear that…
