BIOBANKING
assessment bodies (CAB) operating biobanks in the areas of defined biological materials from human, animal, plant and microorganisms as well as related information and data. The ISO 20387:2018 standard specifies
general requirements for the competence, impartiality and consistent operation of biobanks, including quality control requirements to ensure biological material and data collections are produced and maintained appropriately. This standard is applicable to all
As an estimate there are currently over 570 biobanks from 20 member states in Europe that form the Biobanking and Biomolecular Research Infrastructure BBMR-ERIC Network.
genome in 2003, and many breakthroughs of groundbreaking research for the understanding and management of critical diseases and health conditions. These repositories also facilitate
the discovery of biomarkers, which are measurable indicators of biological processes, disease states, or responses to treatment. Biobanks also play an important role in drug development by enabling pharmaceutical companies to test the safety and effectiveness of new therapies using stored samples.
Standards and frameworks To set up a biobank of organised samples of human, plant, animal or microbial biological material, accompanied by associated information, there are responsible biobanking practices that should be followed. Responsible biobanking prioritises
ethical considerations and operational standards to safeguard donor rights and maintain public trust. Informed consent is a primary aspect, ensuring individuals fully comprehend the purpose and potential implications of donating their biological samples and data. This consent process also informs donors of their right to withdraw participation at any time. Protecting donor privacy and data
security is another important practice, often achieved through de-identification techniques where personal identifiers are removed or replaced with codes. Biobanks adhere to legal and regulatory frameworks, along with internal governance structures, to manage sample access and data sharing. The biobanking process begins
with obtaining informed consent from individuals who agree to donate their biological materials for research. This step ensures donors understand how their samples and data will be used, stored, and shared. Following consent, samples are collected using standardised protocols to maintain their quality and integrity. After collection, samples undergo
various processing steps, including aliquoting, quality control checks, and the extraction of specific molecules like DNA or RNA. These processed samples are then stored long-term under controlled conditions, often in cryogenic freezers at ultra-low temperatures, such as –80°C or in liquid nitrogen at –196°C, to ensure preservation. Data management systems track each sample and its associated information from collection to distribution.
Best practice and accreditation As we know, biobanks and their biospecimens are critical components for many areas of clinical and basic research. The quality of biospecimens and associated data must be consistent and collected according to standardised methods to prevent spurious analytical results that can lead to artefacts being interpreted as valid findings. A number of international institutions have taken the initiative to develop and publish best practices, which include technical recommendations for handling biospecimens as well as recommendations for ethical and regulatory practices in biobanking. To offer accreditation, UKAS
established a pilot programme to develop the assessment approach and offer accreditation to biobanking conformity
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organisations performing biobanking, including biobanking of biological material from multicellular organisms (eg human, animal, fungus and plant) and microorganisms for research and development. It does not apply to biological material intended for food/ feed production, laboratories undertaking analysis for food/feed production, and/or therapeutic use. Since an expression of interest notice
in April 2019, UKAS hosted a series of webinars for interested parties. Having received several applications, a number of applicants are progressing through the accreditation process with document reviews and pre-assessments underway. The first accreditation to ISO 20387 for biobanking was granted to the NHS Greater Glasgow and Clyde in October 2024. At present there does appear to be
some lack of international harmonisation, as is often the case in science, causing uneven adoption, and insufficient oversight of best practices. This could lead to the prevention of further improvements in biospecimen quality and coordination among collaborators and biobanking networks. In contrast to the more straightforward technical and management issues, ethical and regulatory practices often involve issues that are more controversial and difficult to standardise.
Restricted access to biobanks is problematic Access to biobanks for all should be a straightforward mater; unfortunately that is not always the case. As many readers will be aware, access to biological samples for the development and research of commercial products to combat disease is not always straightforward. There can be many hurdles with paperwork, approval, an application process, and unfortunately quite high costs involved for access to patient samples for commercial companies. With increasing demands for the development of accurate and rapid diagnostic tools for the laboratory, and satisfaction to regulatory compliance, this issue of access to patient samples continues to be a hurdle that many
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