Without biomedical research, medicine, as we know it, would be nothing more than a machine gun affair. In simpler words, biomedical research is the substratum that supports evidence-based medicine. Biomedical researchers study biological and pathological processes in order to prevent and treat disease effectively.
Biological materials for biomedical research include tissues, body fluids, cells, blood, and plant material. These biological materials are essential for research in the fields of biotechnology, medicine, and clinical studies. Consequently, the collection, handling, storage, and preservation of these biological materials are critical. Success in this area can only be made possible with the help of modern biobanking technology.
Why is Biobanking Essential for Biomedical Research
Biomedical research has evolved over the years and this has come with significant benefits such as having a better understanding of rare diseases and enhancing drug research [1]. A key contributor to these monumental achievements is advanced biobanking.
Biobanking is a complex and dynamic field and thus is hard to fit into an exact definition. According to the international standard ISO 20387, biobanking refers to the process of acquiring, storing, preparing, testing, analyzing, preserving, and distributing biological materials.
It has also been defined as the process through which tissue and fluid samples from the body are collected and preserved for use in research to enhance our understanding of physiology and pathophysiology.
Biobanks are biorepositories that contain human (or plant) biological samples and the associated clinical information which is used for medical and biomedical research.
Traditionally, biobanks have been associated with deep-freeze warehouses where biological samples are preserved. Standalone biobanks were also the norm of the past. Things have changed over time and modern biobanks have developed centralized systems that are highly scientific [2]. As a result, modern biobanks have the ability to store several million samples that has made precision medicine a reality.
Centralized biobank infrastructure allows for information and specimen sharing across biobanks. For example, biobanks across a network can query for samples of a disease subgroup that may not be available at a single site. This is a major driver for global research and presents unique opportunities for identifying biomarkers and therapeutic agents.
Types of Biobanks
Biobanks are classified according to the type of specimens they handle. However, irrespective of the types of specimens they store, biobanks provide invaluable data and resources for enabling research. Here is a breakdown of the common types of biobanks.
1. Tissue Biobanks
Tissue biobanks use tissue samples that are obtained from surgeries or autopsies and are fixated for histological examination. Optimum temperature conditions need to be maintained with the ideal temperature being -80°C. Some sources recommend liquid nitrogen to prevent contamination as a result of floating tissue fragments [3]. Cryoprotectants are also recommended to prevent cryoprosthesis.
2. Blood Biobanks
Blood (serum, plasma, or cells) is usually collected in test tubes with preservatives and other additives and subjected to analysis in a biobank. This may include biochemical analysis (serum) or DNA analysis (plasma). For short-term preservation, blood components need to be preserved at (−20 °C) while for long-term storage, a temperature of (−80 °C) needs to be maintained [4].
3. Cell Biobanks
Cellular material is essential for biomedical research. Cell cultures are collected and stored in cell biobanks. Some of the major cell biobanks include the American Type Culture Collection, Cell Cultures GmbH, and the Korean Cell Line Bank. These cell repositories provide cellular material for biomedical research.
4. Organoid Biobanks
Organoids are mini-organs that are cultivated from different types of stem cells. They are self-organizing and similar in structure and function to real organs. Consequently, they can be used in biomedical research and regenerative medicine.
5. Digital Biobanks
Digital biobanks enable the integration of data obtained from biospecimens with data from research institutions or clinical data. Alongside the establishment of digital biobanks, standard operating procedures (SOPs) are developed for the collection, storage, and processing of samples. Digital biobanks provide qualitative biological samples and information that can be used to plan for research programs in the future. They can also be used for retrospective studies. Digital biobanking networks can advance cooperation between research institutions and therefore reduce the high cost of collecting and maintaining biomaterials.
6. Population Biobanks
A population biobank is a large repository that consists of thousands of biological specimens collected from a specific population who may or may not have an underlying pathology. However, biobanks must obtain informed consent from all participants. Furthermore, they must inform the participants about how their genetic information will be shared or used in research. The participants have a right to decide whether they wish to be informed about the results of the research and may withdraw their consent anytime.
Omics as an Opportunity for Biobanking
Omics technologies allow for specialized classification of diseases into molecular subgroups which would not have been possible without major advances in technology. This has led to the categorization of diseases into numerous mini-subgroups that facilitate targeted treatment. Omics-based medicine has accelerated biobanking and created a great opportunity for the pharma industry to understand the complexity of human diseases and develop appropriate custom solutions [5].
Sample Handling Process in Biobanks
Biobanks are responsible for providing high-quality biosamples that have rich clinical information to support academic and pharmaceutical research. To achieve this, they have to follow a highly centralized approach to collect, process, store, and distribute biosamples while ensuring sample integrity [6].
The pre-analytical stage involves the collection of bio-samples, transportation (cold chain regime), and registration at the biobank with correct annotations. Subsequently, the bio-samples can then be preserved and stored under optimum conditions. Before sampling, the accessibility and potential use of the sample need to be considered to minimize errors in the pre-analytic phase. It is important to adhere to ISO 20387, ISBER best practices, quality control, and standardization to minimize the heterogeneity of biobanks [6].
Biobanks must ensure that all their processes are transparent and efficient. They must also follow international standards and best practices to ensure that the data generated is reliable and reproducible. Furthermore, biobanks must maintain the integrity of the data at all times. A biobanking LIMS, also known as biorepository management software, needs to be in place for the efficient management of biobanks.
Biobanks must carry out all their procedures in adherence to set protocols. Each step of the workflow needs to be documented. Key considerations include maintaining constant temperatures and having a backup system in place in case of an emergency.
Legal and Ethical Considerations
Biomaterials that are collected by biobanks may be obtained from patients undergoing diagnostic or therapeutic procedures or they could be voluntarily donated by research participants. The materials can be used in specific research or stored for future research. These materials are subject to ethical considerations including privacy in the handling of sample information, acceptable access to and use of the samples, and special status accorded to the human body or body parts.
The identity of the samples can either be identified, coded, or anonymized in the event that the sample was never linked to a particular individual in the first place.
Informed consent is necessary to protect the rights of the participants. The General Data Protection Regulation (GDPR) contains principles that regulate the collection and processing of personal data of the citizens of the European Union for research [7]. The consent of minor participants in research is another important ethical consideration. In most cases, the parents or legal guardians have the right to give or withhold consent.
International organizations such as the BBMRI-ERIC and ISBER provide guidelines on quality management of biological samples.
Biobanks & Big Data Management
Biobanks handle millions of samples and accompanying information about the collection, preparation, analysis, testing, distribution of samples. While doing this, they must adhere to strict biobanking regulatory guidelines such as HIPAA, EU GDPR, and ISO 20387:2018. They must maintain the meta data for the samples to ensure that it is useful for the research objective. A biospecimen management software could help to reduce the operational costs of biorepositories, enforce workflows and maintain data integrity at the same time.
Author: Shonali Paul, Chief Operating Officer at CloudLIMS.com
References
- Drews J. Evolution of biomedical science and the future of drug research. European Journal of Pharmaceutical Sciences. 1995; 3 (4): 187-194. https://doi.org/10.1016/0928-0987(95)00016-7.
- Freedman LP, Cockburn IM, Simcoe TS. The Economics of Reproducibility in Preclinical Research. PLoS Biol. 2015; 13(6): e1002165. https://doi.org/10.1371/journal.pbio.1002165
- Shabihkhani M, Lucey GM, Wei B, et al. The procurement, storage, and quality assurance of frozen blood and tissue biospecimens in pathology, biorepository, and biobank settings. Clinical Biochemistry. 2014; 47 (4): 258-266. https://doi.org/10.1016/j.clinbiochem.2014.01.002.
- Boyanton BL Jr, Blick KE. Stability Studies of Twenty-Four Analytes in Human Plasma and Serum. Clinical Chemistry. 2002; 48 (12): 2242–2247. https://doi.org/10.1093/clinchem/48.12.2242
- Karczewski KJ, Snyder MP. Integrative omics for health and disease. Nat Rev Genet. 2018;19(5):299-310. https://doi:10.1038/nrg.2018.4
- Pitt KE, Campbell LD, Skubitz APN, et al. Best Practices for Repositories I: Collection, Storage, and Retrieval of Human Biological Materials for Research. Cell Preservation Technology. 3(1), 5-48. https://doi.org/10.1089/cpt.2005.3.5
- Paul S. Empowering Biobanks to Comply with the EU GDPR for Personal Data Protection using a Cloud-based LIMS. CloudLIMS. https://cloudlims.com/lims-posters/empowering-biobanks-to-comply-with-the-eu-gdpr-for-personal-data-protection-using-a-cloud-based-lims.html. Published October 14, 2019. Accessed March 23, 2021.
