title: Quality Assurance in Biobanking for Pre-Clinical Research.
abstract: It is estimated that not less than USD 28 billion are spent each year in the USA alone on irreproducible pre-clinical research, which is not only a fundamental loss of investment and resources but also a strong inhibitor of efficiency for upstream processes regarding the translation towards clinical applications and therapies. The issues and cost of irreproducibility has mainly been published on pre-clinical research. In contrast to pre-clinical research, test material is often being transferred into humans in clinical research. To protect treated human subjects and guarantee a defined quality standard in the field of clinical research, the manufacturing and processing infrastructures have to strictly follow and adhere to certain (inter-)national quality standards. It is assumed and suggested by the authors that by an implementation of certain quality standards within the area of pre-clinical research, billions of USD might be saved and the translation phase of promising pre-clinical results towards clinical applications may substantially be improved. In this review, we discuss how an implementation of a quality assurance (QA) management system might positively improve sample quality and sustainability within pre-clinically focused biobank infrastructures. Biobanks are frequently positioned at the very beginning of the biomedical research value chain, and, since almost every research material has been stored in a biobank during the investigated life cycle, biobanking seems to be of substantial importance from this perspective. The role model of a QA-regulated biobank structure can be found in biobanks within the context of clinical research organizations such as in regenerative medicine clusters.
authors: Medservice, Biobanking Consulting &amp; Services, Walchwil, Switzerland.
authors: Daniel
authors: D
authors: Simeon-Dubach
authors: Wyss Translational Center Zurich, Regenerative Medicine Technologies Platform, University of Zurich and ETH Zurich, Zurich, Switzerland.
authors: Steffen M
authors: SM
authors: Zeisberger
authors: Wyss Translational Center Zurich, University of Zurich and ETH Zurich, and Institute of Regenerative Medicine, University of Zurich, Zurich, Switzerland.
authors: Simon P
authors: SP
authors: Hoerstrup
keywords: Biobank; Clinical research; Pre-clinical research; QA; Regenerative medicine; Translational medicine