Basic Principles of Biobanking: From biospecimens to precision medicine for patients

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This article aims to discuss the basic principles of biobanking. 

It includes:

  1. Definitions and classification systems
  2. Standardization processes and documents
  3. Sustainability, and 
  4. Ethical and legal requirements

The article also focuses on the next-generation biobanking, cancer biobanks, infrastructures supporting the implementation of biobanking in scientific research.

Biobank definitions

One of the first definitions of biobank was –  “A collection of biological material and the associated data and information stored in an organized system, for a population or a large subset of a population.”  

It was later updated as – “Structured resources that can be used for the purpose of genetic research and which include (a) human biological materials and/or information generated from the analysis of the same and (b) extensive associated information.”

Watch this video by Mayo Clinic know more about biobanks. 

Biobank key features

Some of the key features that differentiate biobanks from other biospecimen collections are: 

  1. Coexistence of biological specimens and associated data
  2. Not static “projects,” specimens and data collected on a long term basis
  3. Associated with both current and future research projects
  4. Apply coding or pseudonymization to assure donor privacy 
  5. Participants can be reidentified to provide clinically relevant information to the donor 
  6. Include established governance structures and procedures that serve to protect donors’ rights and stakeholder interests
  7. Focused on public interest

Classification systems 

Biobanks are heterogeneous and can differ in size, purpose, and procedures. 

At the first level, biobanks were classified as: 

  1. Population-based biobanks: Biobanks that collect specimens from the general population to study factors associated with various disorders. 
  2. Disease-based biobanks: Biobanks that collect specimens for specific diseases. 

Further classifications were done based on: 

  1. Type of specimens
  2. Type of participants 
  3. Collection methods and design: Prospective, retrospective, etc. 
  4. Nature of intended user: Single group, multiple groups, etc. 
  5. Virtual biobanks: an electronic repository of biospecimens and related data

What to know when building a biobank?

According to the IARC, the following key features should be considered when creating a biobank:

  • Type, number, aliquots, size of biospecimens
  • Storage containers
  • Storage temperature and conditions
  • Frequency of access to biospecimens
  • Requirements for identification of biospecimens
  • Availability of storage space
  • Requirements for temperature monitoring
  • Associated data
  • Financial and operational sustainability

An essential aspect of creating, reliability, and sustainability of a biobank is the standardization of processes connected with sampling, storage, and quality control (QC). Information technology (IT), data systems, and record administration are also critical aspects of biobanks, and efforts should be made to guarantee that these elements are effective and secure. Biobanks shall ensure not only traceability of biological material and associated data but also destruction. 

Finally, biobanks should define disaster recovery plans to avoid the loss of biological material following natural and human-made disasters.  

Financial and operational sustainability

Most biobanks do not have plans for long-term sustainability; rather, they are supported by public research funding. It is demonstrated that financial sustainability can only be achieved if the biobank applies a cost recovery policy based on user fees that reflect the actual costs faced by biobanks.

There is not yet a general or accepted procedure to reach financial sustainability; however, combining traditional ways to new approaches to build novel sustainability and business models that respond to specific requirements of biobanks may be critical.

International infrastructures dedicated to biobanks

  1. The International Society for Biological and Environmental Repositories (ISBER): One of its main aims is to produce guidelines to guarantee high-quality specimens for future research.
  2. The European, Middle Eastern, and African Society for Biopreservation and Biobanking (ESBB): Its mission is to improve biospecimen sharing by encouraging and educating the biobank community. It promotes collaboration between biobanks. 
  3. Biobanking and BioMolecular Resource Research Infrastructure (BBMRI): Aims to provide access to quality-controlled biospecimens and associated data for cross-biobanking research. It currently consists of 21 European member states, international organizations, and observers. 

A focus on cancer oriented biobanks

Cancer biobanks collect specimens from cancer patients and healthy individuals (control) with associated data. These specimens are very helpful to study disease progression. They are collected at various time points, e.g., before therapy, after therapy, follow-up visits, in case of relapse. 

Pathology laboratories play essential roles in cancer biobanks since specimens are collected during diagnostic and treatment procedures. Standard operating procedures must be in place to avoid specimen quality deterioration due to preanalytical issues. E.g., in FFPE tissue samples, fixation time is important since formalin fixation impacts DNA/RNA fragmentation and therefore affects the success of downstream molecular analyses.

Each step in the specimen workflow is critical to guarantee the success of precision medicine since the quality of the sample is the fundamental prerequisite for any reliable data analysis, right from either single biomarker investigations to high-throughput studies.

Next-generation biobanking to increase precision in medicine

Interest in biobanking activity has recently been addressed to new products and procedures required by new research approaches. Biological samples that are stored for research purposes are indeed changing e.g.

  1. Vital or stem cell banking
  2. Patient-derived xenograft (PDX) and patient-derived organoid (PDO) cultures
  3. Extracellular vesicles 

Stem cell banking can help study many types of diseases. PDX/PDO models help in understanding the therapeutic effects of various drugs. To biobank these biospecimens, it is necessary to develop SOPs with guidelines for collecting, storage, and transportation. 

Other novel vital aspects that are currently being evaluated in the scenario of biobanking tending to precision medicine are –

  1. Metabolomics or lipidomics: Can provide valuable data on disease evolution and prognosis or reactions to nutrition or drug compounds. 
  2. Sequential sampling: Multiple samples from the same patient collected at different time points in specified clinical contexts for biomarker investigation and discovery

Unlike classic biobanking, next-generation biospecimens are likely to be collected more frequently within the context of therapeutic trials, with specific requirements. The biobanking costs are likely also to be covered by clinical research budgets.

Biobanking at the time of COVID19 pandemic

The COVID-19 pandemic has led to a new, critical and urgent challenge in the field of biobanking. It also highlighted the power of biobanking and the need for accurate quality assurance, traceability, and financial investment in biobanking.  

BBMRI-ERIC has developed SOPs for biobanks to handle the collection and storage of COVID specimens. They have included an important disclaimer in its document that samples should be collected only by biobanks that are properly equipped. Biobanks should strictly observe the WHO laboratory biosafety guidance related to COVID-19. 

The Centers for Disease Control and Prevention (CDC) of the USA have published guidelines for managing COVID-19 specimens. Some biobanks, such as the University of California San Francisco, have established their guidelines. 

International standard ISO 20387:2018: “Biotechnology – Biobanking – General requirements for biobanking” 

In 2018, the first ISO document (ISO 20387:2018) aiming to define the general requirements for the competence, impartiality, and consistent operation of biobanks was released. It addressed all organizations performing biobanking for research and development. ISO 20387:2018 allows biobanks to obtain accreditation for their activities, thus formalizing their competence. 

Conclusion

Biobanks are crucial in precision medicine research. When addressing tissue-based research, particularly with cancer tissues, collaboration with pathology laboratories that curate tissue samples is of the utmost importance. 

Next-generation biobanking is rapidly evolving. They demand safety, reliability, efficiency, and trust. To fulfill these requirements, ISO standards, which are documents that comprise rules, guidelines, processes, specifications, or characteristics to standardize procedures and allow users to perform tasks in consistent and repeatable ways, are available. 

Finally, for biobank operations, participation by dedicated international infrastructures is advisable. This can facilitate networking, encourage education, improve standardization, and support recognition of biobanks as a vital part of scientific productivity.

Reference:

https://link.springer.com/article/10.1007/s00428-021-03151-0