Biorepositories have become extremely important in clinical care as well as research due to progress in converting basic science findings into clinically actionable tests. The overall goal of a biorepository is to provide high quality specimens that “most closely resemble the biospecimen prior to its removal…” for research or clinical uses through application of pre-analytic standard operating procedures. Substandard specimen quality leads to poor quality research with irreproducible results, doubtful validity of biomarkers, and poor-quality patient care.  Genomic and proteomic technologies used for analyses have raised the bar for specimen quality. The specimens can be tissue or body fluids and consist of diseased tissue or control material.  The activities of biorepositories must include verification of subject or patient consent as necessary, collection, processing, tracking, storage, quality control/quality assurance before specimen use, annotation, and distribution of material.

In the clinical trials setting, biorepositories are important for retrospective correlative biomarker studies using existing materials, for prospective integrated biomarkers and integral biomarkers that direct assignment to therapeutic arms, and for prospective biobanking for future use. Evidence-based understanding of the factors that influence biospecimen quality is incomplete due to lack of research and conflicting results, but areas of importance have been identified:

• Patient characteristics including intravenous fluids, anesthesia and fright response
• Intra- and intertumoral heterogeneity
• Seasonal and diurnal variation
• Specimen containers
• Biopsy, FNA, and surgical manipulation
• Warm ischemia time
• Cold ischemia time, including postmortem time
• Fixative type, temperature and duration
• Decalcification
• Histologic processing conditions and stains
• Storage temperature, humidity and duration
• Freezing and thawing conditions
• Histologic processing conditions and stains

Best Practices for Biospecimen Resources, 2011 edition, from the National Cancer Institute, USA; Best Practices for Repositories, 2012, from the International Society for Biological and Environmental Repositories;  Biospecimen Reporting for Improved Quality guidelines; and Standard Analytical Coding for Biospecimens provide excellent resources for establishing and maintaining a high-quality biorepository.