Challenges for quality management in implementation, maintenance, and sustainability of research tissue biobanks.

Availability of high-quality human tissue samples and access to associated histopathological and clinical data is essential for basic and translational biomedical research, especially in areas of personalized medicine, drug, and biomarker development and mechanistically oriented biomedical research projects. Therefore, it is pivotal to establish and maintain quality-assured tissue biobanks that provide high-quality biomaterial to research thereby increasing the impact and reliability of scientific results. Quality concerns do not only address the biomaterial specimen itself but include all biobanking-related procedures. Tissue biobanks thus face essential challenges that encompass the implementation of adequate structural components, documentation of tissue sample collection and storage (procedures), as well as data and project management and IT. An integral and indispensable component of tissue biobanks is expert-driven evaluation (entry and exit controls) of tissue specimen to guarantee provision of high-quality assured biomaterials.