Biobanks as producers of reference materials

Fay Betsou*

*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceedingChapterpeer-review


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.

Original languageEnglish
Title of host publicationBiobanking of Human Biospecimens
Subtitle of host publicationPrinciples and Practice
PublisherSpringer International Publishing
Number of pages14
ISBN (Electronic)9783319551203
ISBN (Print)9783319551180
Publication statusPublished - 6 Jul 2017
Externally publishedYes


  • Biobank
  • Biospecimen
  • Certification
  • Characterization
  • Fit-for-purpose
  • ISO Guide 34
  • Nominal value
  • Processing
  • Purity
  • Reference material
  • Stability


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