The Biobank of the Human Genetics Laboratory at the Giannina Gaslini Institute achieves ISO 20387 accreditation

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The Biobank of the Human Genetics Laboratory at the Giannina Gaslini Institute has recently obtained ISO 20387 accreditation for its biobanking activities involving human biological material. This achievement makes it only the second biobank in Italy to receive this important recognition, underscoring its excellence and full compliance with the international standard UNI EN ISO 20387:2024. 

The accreditation covers the collection and management of a wide range of biological materials and associated data from individuals affected by genetic diseases. These include peripheral blood, serum, plasma, PBMCs, urine, cerebrospinal fluid, genomic DNA and cell lines.  

Biobanking for the future 

The Biobank’s mission is to support research by providing standardised, high-quality collections of biological samples that are preserved over time and derived from individuals with the same disease, including those with undiagnosed or genetically unexplained conditions.  

In addition, the Biobank offers families the opportunity to store biological samples that may prove valuable for retrospective diagnoses or future diagnostic re-evaluations using advanced technologies. At present, the Biobank holds approximately 20,000 samples from 14,000 individuals, representing more than 200 different genetic syndromes. Since 2008, it has been part of the Telethon Network of Genetic Biobanks and, in 2014, it joined BBMRI-ERIC.   

Evidencing excellence 

The ISO 20387 accreditation evidences that the Biobank operates competently and impartially, following rigorously defined procedures for the collection, preservation, management, and distribution of samples. This guarantees the safe and reliable handling of biological specimens and related clinical data, an essential prerequisite for robust scientific research that ultimately benefits patients. Dr. Domenico Coviello, Director of the Biobank, explains: 

“The ISO 20387 Quality Label is a major recognition for our Biobank. It highlights the daily commitment of the Human Genetics Laboratory and Biobank staff and strengthens the Gaslini Institute’s role as a leading center for biomedical research. By ensuring the preservation of high-quality biological samples, our researchers will have even more powerful tools to advance early diagnoses, targeted therapies and personalised care pathways.” 

The Biobank has also received the BBMRI-ERIC Quality Label, further recognising the excellence of its biobanking activities. Dr. Coviello adds:  

“Furthermore, obtaining the BBMRI-ERIC Quality Label through the fast-track process was a valuable opportunity for us. I am confident that this label will enhance our visibility within the BBMRI Directory, build trust with researchers and partners and open new avenues for collaboration.” 

Commenting on the process of achieving the Quality Label, Chiara Baldo, Biobank Manager, adds: 

“Achieving the Quality Label was both a demanding and rewarding experience for our team. Thanks to our existing ISO 9001 certification, we already had strong procedures in place, which gave us confidence throughout the process.  

“At the same time, we carried out a thorough review and validation of our internal workflows to ensure full compliance with the standards. There were challenging moments, but the dedication of our staff, together with the unwavering support of the Institute, made this success possible.” 

Andrea Wutte, MSc, Head of Quality Management at BBMRI-ERIC says:  

“Congratulations to the Biobank at the Giannina Gaslini Institute on achieving ISO 20387 accreditation – a significant milestone that reflects their commitment to quality and excellence. 

“We’re also pleased they chose to complement their accreditation with the BBMRI Quality Label via our fast-track route. It’s a great example of how accredited biobanks can gain additional visibility and trust. We hope this inspires others to consider the Quality Label – whether through fast-track or our full BBMRI-ERIC audit programme.”