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The Central Biobank Erlangen (CeBE) at Universitätsklinikum Erlangen has achieved the BBMRI Quality Label. Established in 2020, CeBE is a relatively young biobank, making this recognition an important milestone for the biobank and its team. The award confirms CeBE’s commitment to high-quality biobanking and demonstrates that the strategic, early implementation of a quality management system in accordance with DIN EN ISO 20387 has paid off.
The Quality Label was awarded following three audits conducted by the German Biobank Network (GBN). The first on-site audit took place in March 2023, when CeBE was not yet operational, meaning that only theoretical workflows could be evaluated. Based on the auditors’ recommendations and supported by strong collaboration within the CeBE team, the biobank began processing its first samples in its own laboratory in February 2024. The final two audits were performed remotely in October 2024 and June 2025. They were carried out by the auditors Angelika Zablewski, Esther Gimmler and Nhutuyen Nguyen and were successfully completed with only minor, non-critical deviations. CeBE would like to thank the excellent GBN audit team for their constructive and valuable feedback throughout the process.
CeBE is an independent biobank that operates its own laboratory for the processing of liquid samples and maintains multiple storage facilities. Tissue samples are processed and archived by the Institute of Pathology as part of CeBE. In addition, CeBE serves as an umbrella organisation for currently 32 associated biobanks within Universitätsklinikum Erlangen that have joined CeBE through membership. Member biobanks are committed to implement CeBE’s quality management system, which is monitored through internal audits. The Quality Label further supports CeBE’s preparations for DIN EN ISO 20387 accreditation, scheduled for 2026.
Commenting on the achievement PD Dr. rer. nat. Dr. habil. med. Matthias Rübner, Managing Director of CeBE, says:
“Receiving the BBMRI Quality Label is a great honour for us as a young biobank. It highlights the achievements and the high quality of our work over the past few years and confirms that our work meets current European quality standards for biobanking. This recognition not only strengthens our position within Erlangen but also enhances our visibility across Germany and Europe.”
Prof. Dr. med. Bernd Wullich, Spokesperson of CeBE, adds:
“By obtaining the Quality Label, we fulfill the rigorous quality standards of major third-party funding bodies such as the German Research Foundation (DFG) and the Deutsche Krebshilfe (DKH). This positions Universitätsklinikum Erlangen as a leading and competitive site for collaborative research and excellence funding applications.”
Alfred Gemmel, Quality Manager CeBE, says:
“Since the foundation of CeBE in 2020, our objective has been to establish and operate a biobank under a structured quality management system in accordance with DIN EN ISO 20387. With the commitment of all staff members, we have succeeded in not only documenting our processes but also actively implementing them in a structured manner. Supported by the GBN audit program, our processes have been improved continuously and further developed. The Quality Label confirms these efforts and marks a key milestone on our journey to accreditation in 2026.”
Dr. Maike Tauchert, Deputy Head of Quality Management at BBMRI-ERIC, highlights:
“We are delighted to welcome CeBE to the growing circle of biobanks with a BBMRI-ERIC Quality Label. It is great to see what has been achieved in such a short time since the biobank was founded, because quality management is integrated as a central pillar and the biobank processes were established from the outset based on relevant international standards. We wish this dedicated team all the best on their way to accreditation according to the ISO 20387 standard.”
More on BBMRI-ERIC audit programme and Quality Label.