Construction and development characteristics of biological sample banks in the era of precision medicine
2022-5-31 8:23:00Fruit transformation, sharing norms, intellectual property distribution, etc., need to integrate multiple basic disciplines, and sample database practitioners need to continuously enrich and learn various knowledge and skills. At present, some medical colleges and universities in China have established biobanking majors to cultivate professional talents for the field of biobanking.
3 Development stages of biobanks in the era of precision medicine
The development stage of biobanking and the development stage of precision medicine are advancing simultaneously. With the development of precision medicine, the construction of biobanks is guided by precision medicine projects, which has become an effective solution to increase its value and utilization; when the biobanks develop to a more mature stage, they will better support precision medicine. development of.
3.1 Primary stage: an integrated platform for biological samples and information resources
In the initial stage, infrastructure construction will be started, standardized work procedures will be formulated, the collection and standard formulation of biological samples and information resources will be carried out, and a working platform for the collection and management of biological samples and their clinical information will be initially established. This stage is the basic stage of the construction of the biological sample bank, which can complete and realize the "input" function of sample resources and biological information. The main elements that make up biobanks and information banks include various types of entity samples, biological sample derivatives, relevant ethical documents (such as informed consent, etc.), as well as donor clinical information, laboratory testing information, omics data, etc. Researchers can carry out research and verification related to precision medicine from multiple levels, and the data generated is still returned to the sample database, which is integrated with the original physical samples and information data, and continuously enriches and expands the connotation of the biological sample database.
3.2 Intermediate stage: a support service platform for precision medical research
The intermediate-stage biological sample library not only serves as a place for sample collection and storage, but also provides various technical service platforms to realize the transformation of biological sample resources and research data, such as sample storage platform, biological macromolecular extraction and detection platform, tissue, cell, molecular and other multi-level test platforms, as well as downstream refined processing and processing platforms for biological samples. According to the research needs of precision medicine, focus on major clinical diseases, establish screening technology systems such as biochip data analysis, proteomic data analysis, and high-throughput bioinformatics for human diseases, and form corresponding bioinformatics data mining and technology development capabilities, one-stop to obtain the required information and data. This stage is a key stage in the construction of the biobank, and it is the role transformation stage of the biobank from a clinical sample information resource collection platform to a precision medical research project support service platform.
3.3 Advanced stage: a platform for transformation and cooperation of precision medical achievements
The construction and maintenance of biological sample banks requires a lot of investment. The rational development of a service value system for the paid use of biological samples for the operation and maintenance of biological sample banks is an effective way to realize the value attributes of biological sample resources and ensure the sustainable development of biological sample banks. In 2016, the "Thirteenth Five-Year Plan for the Development of National Strategic Emerging Industries" issued by the State Council[12] clearly pointed out that a biological resource sample bank, a biological information database and an integrated system of biological resource information should be built, and the construction of an integrated system with important industrial application value should be established. And a forward-looking national high-quality sample database and a real-time panoramic life database to build a basic support platform for information resource research and development. At the same time, it is pointed out that relying on the existing bio-industry bases, parks and clusters, it is necessary to promote the construction of several bio-economic clusters in a step-by-step and focused manner, promote the concentration of talents, technologies, capital and other resources in advantageous areas, and guide the characteristic and agglomerated development of the bio-industry. Make the bio-industry play a leading role in promoting industrial transformation and upgrading. Accelerate the construction of a biotechnology innovation and entrepreneurship service platform that runs through the entire innovation chain.
At this stage, biobanks need to seek ways to cooperate with biopharmaceutical companies to establish an integrated database system and technical standards including biological sample databases. On the basis of building a standardized and sharable biological sample big data center and a collaborative network support platform, the storage, transmission and sharing of data of various types of biological samples are realized. , to realize an operable sharing mechanism and cooperation channel of biological sample resources and information resources, reflect the economic value of biological sample resources, provide resources and technical services for scientific research in the fields of biomedicine, clinical medicine and biotechnology in the region, and implement precision medicine. While transforming the results, the sustainable development of the biobank is realized.
4 Problems and deficiencies in the development of biobanks
As an emerging field, biobanking has problems such as unbalanced development among regions, low sample utilization rate, and insufficient resource integration. In the early construction stage of some biological sample banks, due to the lack of perfect top-level design, many detours were taken during the construction process, resulting in the emergence of "dead banks" and "garbage banks", resulting in waste of resources. In addition, the biobank construction project also has many problems and shortcomings in terms of data security, ethical disputes and sustainable development.
4.1 Data security and privacy protection issues
In the development process of precision medicine, mobile medicine and big data technology are widely used, and the privacy protection of patients and the ethical issues caused by genetic technology emerge. In the era of big data, the value of personal information is increasingly recognized by the market and various industries, and the value and mining of data information is becoming more and more important. At present, the boundaries of sharing and rights protection of big data based on biobanks are still unclear. At the same time, driven by profits, the frequent incidents of illegal use of personal information have caused many issues such as privacy protection, ethics, and law, and hindered the development of big data application technology. Regarding issues related to informed consent and donor privacy protection, there is currently no unified consensus and norm, and no country has issued relatively systematic and comprehensive laws and regulations[13].
4.2 Sustainability Operation Issues
The research and development of precision medicine is costly, especially the research and development cost of targeted drugs is high. In order to ensure the orderly development of precision medicine, especially the research and development of precision medicines, continuous financial support is a necessary condition, and financial investment alone cannot achieve the possibility of industry development. At the same time, through policy support, pharmaceutical companies should be allowed to legally obtain corresponding profits, so as to promote the active participation of social capital and inject sufficient funds into the development of precision medicine [14]. At present, the operating funds of domestic biobanks mainly come from the support of major national, provincial and municipal projects and the infrastructure investment of hospitals. In the process of operation, they face the problem of how to carry out "self-hematopoiesis". It is recommended to broaden the channels of economic sources and find suitable development for them. Model, carry out cooperative research and development projects with related companies in the field of precision medicine, and realize the value transformation of sample resources.
5 Summary
The development of human society has entered the era of artificial intelligence, and intelligent technology has had a greater impact and impact on the development of all walks of life. In the field of precision medicine, artificial intelligence has become an important development direction for innovative drug research and development and precision medicine. In the near future, intelligent diagnostic analysis technology will bring subversive changes to the existing medical model. In recent years, large-scale automated intelligent equipment for biological sample banks has been popularized, and intelligent automatic sample processing, storage, and testing equipment based on Internet of Things technology has been continuously introduced. In addition, the "living" sample library, known as the next-generation biological sample library, uses technologies such as primary cell culture and recovery, and cell reprogramming to obtain a large number of research materials that can truly reflect the biological state of the body from a limited sample size. Breaking through the existing bottleneck of biological sample banks and meeting the higher requirements of precision medicine is the future development direction of biological sample banks and has broad development prospects.