The importance of biobanks in research and development

June 16th, 2020, by Pierre Dégousée

Also called Biological Resource Centers (BRC), biobanks are structures in charge of the collection, storage and provision of biological samples and their associate data. Their objective is to permit scientific advances for the benefit of patients and populations. Here is an overview of these crucial facilities for R&D.

Biobanks and BRC, at the heart of R&D

The history of biobanks

The collection and storage of biological samples derived from humans, animals or plants is not a particularly new practice, but it has only been acknowledged during the 90s. The word “biobank” made its appearance in scientific literature in 1996 ; and the expression “Biological Resource Center” has been adopted in 1999 during the Workshop Tokyo ’99 on Scientific and Technological Infrastructure – Support for BRCs of OECD. France will then approve this name and its acronym “BRC” in 2001.

Biological resources (i.e. biological samples associated with their corresponding data) constitute an essential raw material for progress in biotechnologies, health and R&D in life sciences. The latest revolution in the molecular biology field (caused by the DNA sequencing and studies on the functions of genes) resulted in a worldwide increased demand for biological resources. This led many biobanks to be built on wobbly foundations. This heterogeneity in biobanking practices has motivated OECD to determine global guidelines for biobanks. As a result, the organization published in 2001 and 2007 two best practice reports that are still used to this day.

Biobanks are fundamental to harnessing and preserving the world’s biodiversity and genetic resources; they serve as an essential element of the infrastructure for scientific investigation and R&D. However, biobanks face many challenges for their development, expansion and survival. These include problems raised by the molecular revolution, by the efforts for biodiversity, by public funding uncertainties, by the need for adequate quality assurance and by national and international jurisdiction. Biobanks are therefore dynamic structures that depend on many factors, including financial, ethical and legal aspects but also medical influences: use of biological collections greatly depends on scientific advances and developments in medicine.

Biological resources play a key role in today’s biomedical research: the advent of personalized medicine and the crucial role played by biomarkers, especially in oncology, have contributed to this evolution. This progress led to the creation of tumor banks and other very specialized biobanks in the world. Clinical samples can also play a decisive role during experimental design phases, methods for identifying molecules and even when choosing biomarkers for their clinical validation. Research and Development has also deeply changed these past years and is now using more diverse resources and stakeholders, which include biobanks.

Focus on biological resources

Biobanks are service providers and repositories of biological samples for research purposes. They have the possibility to transfer said resources to researchers and public or private R&D structures in order to advance biomedical research. These clinical samples come from healthy or ill persons who previously gave their consent for their samples to be used for science and research. Biobanks and BRC have a wide variety of biological material organized in thematic biological collections, which cover practically all living materials: culturable organisms (e.g. micro-organisms, plant, animal and human cells), replicable parts of these (e.g. genomes, plasmids, viruses, cDNAs), biological fluids, tissue samples, as well as data bases containing molecular, physiological and structural information relevant to these collections and related bioinformatics. This allows biobanks to cover most requests from researchers.

Biobanks and their respective biological collections serve a multitude of functions and take on a wide range of shapes and forms. Some are large national centers providing access to diverse organisms, while other biorepositories provide limited but crucial specialized resources (e.g. tumor banks, cell banks, serum banks). Furthermore, biobanks must be able to provide researchers at any time the products and services they need. Biobanks must also be guaranteed to supply reliable, high-quality biological resources and information in order to ensure their reproducibility and sustainability.

The ethical and legal framework for biobanking practices

Most resources held by biobanks come from human organisms, which make using them much more delicate than other biological resources. Fortunately, specific laws provide a solid framework for biobanking practices in order to ensure data integrity and to secure clinical samples and their owners, whose anonymity must absolutely be preserved. In matters of bioethics, French laws are particularly clear towards the use of biological samples: any research project requiring biological material needs to be validated by an Institutional Review Board (IRB) and the French National Agency for Medicine before it begins.

AFNOR certifications are also a requirement for biobanks to perform their activities. They are generally renewed every three years, and their obtention depends on the quality management system of the biobank. The NF S 96-900 certificate – which is specific to biobanks and BRC – guarantees scientific robustness, security, ethical requirement and economic regulation from the certified biobank; these four pillars are based on the guidelines from OECD’s reports cited above. In that way, biobanks make sure to possess a high-quality regulatory, technical, scientific and medical expertise allowing researchers to optimally use biological resources and their thematic collections. Obtaining clinical samples from a certified biobank is a safe and lawfully means to access high-quality material.

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Pierre Dégousée portait

Pierre Dégousée