Biobank IPO Filing Highlights Role in Advancing Precision Medicine and Biomedical Research
Mar 03, 2022 09:37
CST Updated
09:37
What is a Biobank?
Biobank, generally translated as "biological bank," is also known as a biospecimen repository.
Currently, there are three main types of definitions.
On Baidu Baike, it primarily refers to the standardized collection, processing, storage, and application of samples such as macromolecules, cells, tissues, and organs from healthy and diseased biological organisms (including human organs and tissues, whole blood, plasma, serum, biological fluids, or processed biological samples such as DNA, RNA, and proteins), for the purpose of experimental research.
The Organisation for Economic Co-operation and Development (OECD) defines a biobank as a biological application system that centrally stores various types of human biological materials for clinical treatment of diseases and life sciences research.
The U.S. National Cancer Institute (NCI) defines a biobank as a collection of human biological specimens for research, associated data, the physical entities for data storage, and related processes and policies.
The Historical Origins of Biobanks?
As early as the 1990s, scientists began collecting biological specimens for their own experiments, but the concept and practice of sharing these specimens with other laboratories had not yet emerged. When studying genetic diseases, researchers focused solely on the associations between known genes and disease pathogenesis; for instance, in breast cancer research, scientists at the time considered only the Breast Cancer Susceptibility Genes 1 and 2 (BRCA1 and BRCA2).
In the late 1990s, scientists began to realize that although certain diseases are caused by single-gene defects, most diseases are influenced by multiple genetic defects, rendering experimental approaches focused on individual genes increasingly ineffective. As technological advancements reduced the cost of whole-genome scans to a level comparable with that of single-gene analyses, scientists started to collect genetic data on a large scale. Meanwhile, technology enabled the sharing of genetic information. Researchers discovered that data from whole-genome scans could be applied to a wide range of genetic studies. Ultimately, a genetic database was established to facilitate community-wide data sharing.
Types of Biobanks?
Biobanks are categorized by tissue type into tumor tissues, cells, blood, DNA, or DNA array analysis;
Biobanks are categorized by ownership into private biobanks (such as those operated by academic medical institutions, hospitals, biotechnology and pharmaceutical companies, and biological database storage firms) and publicly owned or government-co-managed biobanks.
Biobank's Biological Specimens
Biobank biological specimens are obtained through sampling, including blood, urine, skin cells, organ tissues, and more. The Biobank properly preserves these specimens until researchers require them for experiments.
Neonatal Blood Collection
A. Specimen Storage
Similar to DNA databases, biobanks must properly store and document sampling procedures and donor information, ensuring that samples are protected from physical damage. All data regarding sample accession and withdrawal, as well as their current physical locations, are comprehensively recorded in a cloud-based system. Information on biological specimen donors is strictly confidential within the archival system, accessible only under stringent controls, including to researchers. The database segregates clinical data from clinical organ and tissue data to safeguard privacy.
The current system is not large and can store 40,000 specimens. Sample replicas and isolated samples are stored separately for security purposes.
B. Ownership of Specimens
A major controversy surrounding biobanks also involves the issue of ownership of physical samples. In 2007, Iceland enacted three laws stipulating that the Icelandic government holds custodial rights over physical samples, while donors retain ownership of these samples. In contrast, Tonga and Estonia have vested ownership of physical specimens in the government, but have also strengthened protections for donors’ rights.
Controversial Issues Surrounding Biobanks
A. Commercialization Disputes:
The intrinsic value of biological specimens can be leveraged; however, when biobanks and their associated projects are publicly funded yet yield benefits for private enterprises, it can easily trigger a crisis of public trust in biobank initiatives.
The project may be more inclined toward profit generation rather than genuine experimental purposes.
B. Genetic Discrimination
How should Biobanks allocate liability when information about research participants or donors disclosed by researchers may give rise to discrimination issues?
C. Institutional Review
How is the check-and-balance role of biobanks manifested?
Given the varying regulations governing biobanks across different countries, how should cross-border research projects be implemented?
D. Privacy Issues of Experimental Participants
To protect the privacy of research participants, the identities of donors of physical specimens are typically kept confidential. However, in many cases, the personal information of research participants is vulnerable to leakage. This risk is particularly pronounced when researchers need to contact donors, or when the security level of data or decryption keys is insufficient. With the use of computer networks, seemingly unrelated fragments of information from donors’ physical specimens can be reassembled to reconstruct complete personal profiles.
Despite scientists’ repeated assurances that donors’ names would not appear in the information data fields, the use of outdated historical preservation methods has significantly compromised security. Furthermore, genetic information from as few as 100 single-nucleotide polymorphism (SNP) loci can independently identify any individual.
Text | Zhou Yanxun
Editor: Mo Renying
Biobank, generally translated as "biological bank," is also known as a biospecimen repository.
Currently, there are three main types of definitions.
On Baidu Baike, it primarily refers to the standardized collection, processing, storage, and application of samples such as macromolecules, cells, tissues, and organs from healthy and diseased biological organisms (including human organs and tissues, whole blood, plasma, serum, biological fluids, or processed biological samples such as DNA, RNA, and proteins), for the purpose of experimental research.
The Organisation for Economic Co-operation and Development (OECD) defines a biobank as a biological application system that centrally stores various types of human biological materials for clinical treatment of diseases and life sciences research.
The U.S. National Cancer Institute (NCI) defines a biobank as a collection of human biological specimens for research, associated data, the physical entities for data storage, and related processes and policies.
The Historical Origins of Biobanks?
As early as the 1990s, scientists began collecting biological specimens for their own experiments, but the concept and practice of sharing these specimens with other laboratories had not yet emerged. When studying genetic diseases, researchers focused solely on the associations between known genes and disease pathogenesis; for instance, in breast cancer research, scientists at the time considered only the Breast Cancer Susceptibility Genes 1 and 2 (BRCA1 and BRCA2).
In the late 1990s, scientists began to realize that although certain diseases are caused by single-gene defects, most diseases are influenced by multiple genetic defects, rendering experimental approaches focused on individual genes increasingly ineffective. As technological advancements reduced the cost of whole-genome scans to a level comparable with that of single-gene analyses, scientists started to collect genetic data on a large scale. Meanwhile, technology enabled the sharing of genetic information. Researchers discovered that data from whole-genome scans could be applied to a wide range of genetic studies. Ultimately, a genetic database was established to facilitate community-wide data sharing.
Types of Biobanks?
Biobanks are categorized by tissue type into tumor tissues, cells, blood, DNA, or DNA array analysis;
Biobanks are categorized by ownership into private biobanks (such as those operated by academic medical institutions, hospitals, biotechnology and pharmaceutical companies, and biological database storage firms) and publicly owned or government-co-managed biobanks.
Biobank's Biological Specimens
Biobank biological specimens are obtained through sampling, including blood, urine, skin cells, organ tissues, and more. The Biobank properly preserves these specimens until researchers require them for experiments.
Neonatal Blood Collection
A. Specimen Storage
Similar to DNA databases, biobanks must properly store and document sampling procedures and donor information, ensuring that samples are protected from physical damage. All data regarding sample accession and withdrawal, as well as their current physical locations, are comprehensively recorded in a cloud-based system. Information on biological specimen donors is strictly confidential within the archival system, accessible only under stringent controls, including to researchers. The database segregates clinical data from clinical organ and tissue data to safeguard privacy.
The current system is not large and can store 40,000 specimens. Sample replicas and isolated samples are stored separately for security purposes.
B. Ownership of Specimens
A major controversy surrounding biobanks also involves the issue of ownership of physical samples. In 2007, Iceland enacted three laws stipulating that the Icelandic government holds custodial rights over physical samples, while donors retain ownership of these samples. In contrast, Tonga and Estonia have vested ownership of physical specimens in the government, but have also strengthened protections for donors’ rights.
Controversial Issues Surrounding Biobanks
A. Commercialization Disputes:
The intrinsic value of biological specimens can be leveraged; however, when biobanks and their associated projects are publicly funded yet yield benefits for private enterprises, it can easily trigger a crisis of public trust in biobank initiatives.
The project may be more inclined toward profit generation rather than genuine experimental purposes.
B. Genetic Discrimination
How should Biobanks allocate liability when information about research participants or donors disclosed by researchers may give rise to discrimination issues?
C. Institutional Review
How is the check-and-balance role of biobanks manifested?
Given the varying regulations governing biobanks across different countries, how should cross-border research projects be implemented?
D. Privacy Issues of Experimental Participants
To protect the privacy of research participants, the identities of donors of physical specimens are typically kept confidential. However, in many cases, the personal information of research participants is vulnerable to leakage. This risk is particularly pronounced when researchers need to contact donors, or when the security level of data or decryption keys is insufficient. With the use of computer networks, seemingly unrelated fragments of information from donors’ physical specimens can be reassembled to reconstruct complete personal profiles.
Despite scientists’ repeated assurances that donors’ names would not appear in the information data fields, the use of outdated historical preservation methods has significantly compromised security. Furthermore, genetic information from as few as 100 single-nucleotide polymorphism (SNP) loci can independently identify any individual.
Text | Zhou Yanxun
Editor: Mo Renying