Biobanks as producers of reference materials

As diagnostics and clinical research increase in complexity and inter-dependency, there is an increasing need in the diagnostic and pharmaceutical industries for formal certification of clinical biospecimens for nominal properties, so as to be considered Reference Materials. Certified clinical biospecimens that are collected, processed, characterized, stored and distributed by biobanks will facilitate diagnostic test development, evaluation and quality assurance, raising and harmonizing the standards of regulatory submissions based on clinical biospecimen analysis. For clinical biospecimens, certification relates to qualitative and/or quantitative characteristics of diagnosis (clinical, biological and pathological). For certification, biospecimen purity, characterization, fitness-for-purpose, homogeneity and stability, must be evaluated and thoroughly documented. Much of this data is currently collected by biobanks, however formal requirements are needed and biobanks themselves should be accredited to attribute reference material status by adhering to ISO 17034 requirements. This chapter describes potential biospecimen certification, and illustrates the certification process with some examples, which have been published in Biopreservation and Biobanking 2014; 12:113-120.