Biobank for Translational Medicine: Standard Operating Procedures for Optimal Sample Management

Abstract

Biobanks are key research infrastructures aimed at the collection, storage, processing, and sharing of high-quality human biological samples and associated data for research, diagnosis, and personalized medicine. The Biobank for Translational and Digital Medicine Unit at the European Institute of Oncology (IEO) is a landmark in this field. Biobanks collaborate with clinical divisions, internal and external research groups, and industry, supporting patients' treatment and scientific progress, including innovative diagnostics, biomarker discovery, and clinical trial design. Given the central role of biobanks in modern research, biobanking standard operating procedures (SOPs) should be extremely precise. SOPs and controls by certified specialists ensure the highest quality of samples for the implementation of science-based, diagnostic, prognostic, and therapeutic personalized strategies. However, despite numerous efforts to standardize and harmonize biobanks, these protocols, which follow a strict set of rules, quality controls, and guidelines based on ethical and legal principles, are not easily accessible. This paper presents the biobank standard operating procedures of a large cancer center.

Establishment of a Biorepository for Down Syndrome: Experience of the Inter-Institutional Multidisciplinary BioBank - BioBIM

“…To the best of our knowledge, this is the first dedicated DS biobank in Italy. An advantage of this biobank is its coexistence with a highly specialised laboratory, which has made it possible to carry out verification and analytical tests on the samples to establish the characteristics and criteria for collection and preservation, as demonstrated by scientific papers published as part of the project [29][30][31][32]37]. To date, BioBIM has recruited 454 and 80 individuals with DS and AD, respectively.…”

“…The ambient temperature of the BioBIM building was maintained for all work environments at 18–22 °C. Immediately after collection, the samples were transferred to the BioBIM Laboratory, where they were processed using the most appropriate standard operating procedures [ 29 ].…”

“…This is a data identification and storage technology that allows the tracing of the specific paths of each biological sample until freezing. The RFID system designed and developed at the biobank consists of a device that provides a chronological report of the processes involved in each cryopreservation operation, such as door opening/closing, rack insertion/extraction, sample insertion, and the identification of the laboratory operator [ 29 , 38 ].…”

Building a rheumatology biobank for reliable basic/translational research and precision medicine

“…Even though the outcomes of preclinical research cannot be replicated, many secondary papers are nonetheless created ( 50 ). To counteract this phenomenon, research biobanks use a predetermined procedure for collecting, handling, and storing biological samples that ensures the standardization of the methods, specific training of personnel, and continuous checks on the path and the samples ( 51 , 52 ). Furthermore, biobanks implement quality controls (on both banked samples and collected data) throughout banking procedures to verify the quality of the samples and, consequently, the reliability of scientific results and their application ( 53 ).…”

Standardized pathology report for HER2 testing in compliance with 2023 ASCO/CAP updates and 2023 ESMO consensus statements on HER2-low breast cancer

“…Current ASCO/CAP guidelines recommend the use of Food and Drug Administration (FDA)-approved IHC/ISH assays and periodic inspections of testing laboratories [ 80 ]. Efficient organization of sample storage and laboratory documentation is crucial to facilitate retesting if necessary [ 7 , 12 , 27 , 37 , 41 , 49 ]. The quality of HER2 testing results and adherence to standard operating procedures rely directly on the laboratory personnel, encompassing technicians, molecular biologists, and pathologists [ 4 , 31 , 56 ].…”