Title of Presentation
“Pre-examination process requirements for European biobanks: focus on venous whole blood”
Date and Place
Loes Linsen developed an interest in good quality biobanking due to participation in the European FP6 “CCPRB”-project. From 2008, she worked as biobank manager for the University Biobank Limburg where she set up the organisational structure, including the ethical and legal framework, together with the implementation of a BIMSystem. Loes is also involved in the Flemish Biobank Initiative infrastructure, which houses a harmonized virtual central catalogue of samples for translational research. Since 2016, Loes works at the University Hospitals Leuven Biobank. Her expertise lies in validation of sample processing methods with respect to the sample quality as well as the practical feasibility and the integration into a certified/accredited quality system.
Both academic and industrial researchers are increasingly confronted with the question, whether the biological material employed in their research is of sufficient quality. This is not least due to the fact that about half of all published results remain irreproducible. The resulting costs run into tens of billions of dollars in the USA alone, poor materials are considered the most frequent cause for this scientific and economic disaster. The vast majority of factors influencing the quality of biological material are inherent in the pre-analytical phase. Hence, facilitating standardization and harmonization of pre-analytical procedures could do much to improve research efficacy. Biomedical research is inseparably linked to clinical diagnostics and therapy since it generates the basis for novel biomarkers and therapeutic options. As a result, the quality of research specimen must not undercut the quality required for diagnostic samples. The European Committee for Standardization (CEN) has recently published a set of technical specifications for pre-examination processes. These however, are strongly oriented towards routine workflows. BBMRI-ERIC as such took the initiative and established transnational working groups aimed at operationalizing the specifications for biobank purposes. For venous whole blood, CEN so far published three distinct standards, addressing the isolation and preservation of RNA, gDNA and ccfDNA. BBMRI-ERIC workgroup 3 currently structures the content of these standards as steps of a visualized process. This enables the stepwise evaluation, control and documentation of the depicted process sections. The final objective is to enhance research efficacy by provision of high grade and comparable biological material.