Current Situation and Countermeasures of Biobank Construction in my country

As "improving the capability of independent innovation and building an innovative country" has become the core of my country's development strategy, the development of my country's clinical medical science also urgently needs to enter the stage of independent innovation. As the infrastructure of clinical treatment and medical scientific research, the biobank is the key to promote the innovation of clinical medicine and diagnosis and treatment technology. The construction of a large-scale, high-quality biobank is extremely important for exploring new diagnosis and treatment methods for clinical diseases, developing new technologies and new businesses, and carrying out precise treatment, and provides great help for improving the quality of clinical research [1]. At this stage, the construction level of biobanks in my country is low, the scale is small, and the quality is uneven. It is urgent to improve the construction level and quality. This study analyzes the current situation of biobank construction in my country, discusses the problems and countermeasures in the construction of biobanks, and provides a reference for improving the construction level of biobanks in my country.
 
1 Current status of biobank construction
1.1 Current status of foreign biobank construction

A biobank, also known as a biobank, is an entity organization composed of an entity sample bank and a virtual database for standardized collection, processing, storage and use of entity samples such as tissues, body fluids, DNA, and RNA, as well as those related to these entity samples. information such as pathology, clinical diagnosis and treatment, ethical approval, informed consent and follow-up, as well as information management and data application of related samples, quality control of entity samples and quality control of information management system data [2-3]. Internationally, biobanks are relatively mature. Typical biobank platforms include the International Society for Biological and Environmental Repositories (ISBER), the British Biobank, and the National Cancer Institute (National Cancer Institute). Institute, NCI) Biobank, Denmark National Biobank, etc. Established in 1999, the British Biobank is a large-scale prospective cohort study biobank with 500,000 British volunteers aged 40 to 69 years old and more than 15 million biological samples [4]. The US NCI Biobank was established in 1987 and currently has collected more than 800,000 samples [5]. The Danish National Biobank was established in 2012 and has stored more than 7.98 million biological samples. The total population of the country is more than 5 million. Under the perfect medical system and population registration system, every Dane's biological samples are preserved. And have complete information [6].

In recent years, foreign biobanks have been developing towards automation, large-scale and informatization, forming a top-down (UK Biobank) or bottom-up (NCI Biobank) sharing network of biobanks. The sample library has formulated unified standard specifications, sharing rules and procedures, and established a highly open public information platform, so that all people associated with the biological sample library can obtain the required content through the platform [7]. In August 2018, the ISO 20387:2018 standard was officially released internationally, proposing unified standards in laws and regulations, ethics, informatization, quality and safety, and resource integration and sharing.

1.2 Current status of domestic biobank construction

my country is a country with a large population of 56 ethnic groups. There are many types of clinical diseases and abundant biological sample resources. This is a unique national condition of my country. The number and types of samples in my country in terms of human genetic resources cannot be compared with any other country. Biological samples have the characteristics of diversity and regionality, which provides the basis for the construction of standardized and high-quality biological sample banks in my country. As early as 1994, the Chinese Academy of Sciences established the Chinese National Immortal Cell Bank, which stored the immortalized cell lines of more than 3,000 people and more than 6,000 DNA samples in China [1]. Representative sample banks in my country include the National Gene Bank, Beijing Major Disease Clinical Data and Sample Resource Bank, Shanghai Xinchao Biobank, and China Marrow Bank. Hospitals at all levels have also successively established specialist biological sample banks or general hospital biological sample banks featuring hospital specialist diseases. In order to promote the standardized construction and efficient use of biobanks in China, in 2009, the Biobank Branch (China Medical Biotechnology Association, BBCMBA) of China Medical Biotechnology Association was established to integrate the advantageous resources of member units and establish a national tumor tissue biobank. The sample database and the national network system break the current pattern of fragmentation, mutual isolation, repetition and dispersion in the field of organizational resources.

With the development of precision medicine, the Chinese government has issued a series of policies to promote the development of biological sample banks. The "Healthy China 2030 Planning Outline" proposes to vigorously strengthen the construction of national clinical medical research centers and collaborative innovation networks, and further strengthen the capacity building of scientific research bases such as laboratories and engineering centers. In 2016, the State Council issued the "Notice of the State Council on Printing and Distributing the National Science and Technology Innovation Plan for the 13th Five-Year Plan" (Guo Fa [2016] No. 43), which pointed out that it should focus on the integration, mining and utilization of strategic biological resources, and promote the systematic integration of human genetic resources. With in-depth utilization research, build a national strategic biological resource bank and information service platform, expand resource reserves, strengthen development and sharing, master the initiative in utilization and development, and provide resource guarantees for the sustainable development of the biological industry. In 2017, the Ministry of Science and Technology and other ministries and commissions issued a notice on the issuance of the "National Science and Technology Innovation Base Optimization and Integration Plan" (Guoke Faji [2017] No. 250) [8], proposing to build a number of national clinical medical research centers relying on relevant medical institutions. Integrate clinical medical resources on a large scale, and build a professional clinical medical public service platform such as big data and sample libraries. In 2017, the "Thirteenth Five-Year Plan for Health and Health Science and Technology Innovation Special Plan" issued by the Ministry of Science and Technology clearly required the continuous improvement of the innovation base platform. , vigorously promote the construction of the National Clinical Medical Research Center, coordinate the deployment of platform bases such as the National Medical Big Data and Sample Repository, and build a large population cohort covering 1 million healthy people and 10 key diseases [9]. At this stage, various regional governments, universities and hospitals attach great importance to the construction of biological sample banks, promote the standardization and standardization of biological sample banks, promote the integration of medical research resources, and provide new technologies and methods for disease diagnosis and treatment, and new drug development and evaluation. Support, but also promote the development of translational medicine.

 
2 There is a problem
At present, the biobank industry is in a stage of accelerated development, and the construction of biobanks in many general hospitals is overtaking. However, the development of biobanks in my country is still in its infancy. With the development of the biobank industry, a series of problems have also arisen, such as the lack of a unified standardized process, imperfect laws and regulations, the biological sample discipline has not yet been established, the lack of professional talent teams, the independence of each sample bank and the lack of resources Shared mechanism, low cost-effectiveness of sample bank, lack of self-hematopoietic function, low sample usage rate, etc.

2.1 Lack of a unified standard biobank construction process

The development of precision medicine requires standardized and high-quality biological samples. However, the construction levels of various biological sample banks in my country are different, the standards for sample collection and storage are inconsistent, and the quality control standards for biological samples are also inconsistent. The construction scale and sample quality are uneven [10]. Although many general hospitals in my country have established biological sample banks, there is no unified national standard for the construction of biological sample banks. At present, all biobanks in my country adopt their own standards for establishing databases. In the field of biobanks, there is no unified national standard sampling process and management model, and there is no unified index system and sample quality control system in the information system. It is to build a sample database according to its own scientific research needs [3]. Studies have shown that the development of biobanks in various regions of my country is uneven, and there are large differences in capital investment, site environment configuration, and organization and personnel arrangements among hospitals [11].

In order to further promote the standardization of biobanks in my country and improve the quality of biological samples, BBCMBA organized the inter-laboratory comparison of biobanks and the third-party quality control service project in October 2017. In June 2018, BBCMBA, ISBER and Luxembourg Integrated Biobank signed a project contract to jointly carry out the inter-laboratory quality assessment of Chinese biobanks. Years of inter-laboratory quality assessment and third-party quality control services for biobanks. The above measures have played a positive role in promoting the standardization and standardization of biological sample banks. However, BBCMBA is a non-governmental organization, and relevant national departments need to build a national-level official organization and management system, and build a national standard unified high-quality biological sample bank. It is mandatory for each biobank to be constructed according to unified standards, implement the Healthy China 2030 Plan, and effectively promote the development of Healthy China.

2.2 The biological sample discipline has not yet been established, and there is a lack of professional talent teams

Although the biobank has been established in my country for more than 20 years, it has not yet formed a formal discipline. With the development of the level of science and technology, translational medicine and precision medicine, the construction of biological sample banks in general hospitals in my country has entered a golden age, but the biological sample discipline has not yet been established, and there is a lack of professional talent teams. Personnel from other disciplines have formed a basically complete theoretical system at the stage of full-time higher education, while the staff of the hospital sample bank have not undergone systematic professional theoretical knowledge learning and practical skills training. Work from inside and outside the department to learn to work. At the same time, hospitals also lack assessment standards and professional title evaluation systems for biobank personnel. Most research hospitals are affiliated with laboratory personnel, researchers from universities and hospitals, or laboratory personnel and pathology departments of hospitals, or refer to the standards of administrative personnel. Assessment and title review.

2.3 Lack of resource sharing mechanism

Biobanks provide resources for clinical medical research, but limited sample resources cannot meet the number of cases required for etiology research, so the mechanism of disease occurrence and development cannot be identified. A single project usually affects the statistical results due to the insufficient number of samples, and the large number of samples required for large projects is usually difficult to achieve in terms of manpower, material resources and time. Therefore, the main purpose of biobank construction is to integrate and share biological resources. [12]. The premise of resource sharing of biobanks is the sharing of information resources, which requires a high degree of homogeneity of information resources. At this stage, the construction standards of various biological sample banks are different, the methods and contents of sample collection are different, and the information systems are different. The collection of samples cannot be integrated, which makes the sharing of biological sample resources more difficult and the sample utilization rate is low, so that many sample banks are only stored but not taken, becoming "garbage banks" or "dead banks".

2.4 The sample bank lacks its own hematopoietic mechanism

As a storage place for samples, hospital biobanks not only store physical samples such as tissue, blood, and urine, but also have corresponding information systems for these samples, mainly serving medical scientific research. As a combination of physical resources and information systems of massive data resources, the sample database can provide extremely important resource support for scientific research. Compared with foreign biobanks, the construction of biobanks in my country started relatively late, and their own hematopoietic capabilities were relatively weak. They mainly provided sample resources and storage services, and the ability to provide technical support was relatively weak. At the same time, the lack of economic awareness in the construction of the hospital biological sample bank, the lack of a paid service system for resources and a sustainable development mechanism make the sample bank a high-input and low-output department, which restricts the sustainable development of the biological sample bank to a certain extent. .

 
3 Countermeasures
3.1 Strengthen the standardization of biobanks

High-standard and high-level biological sample libraries are the basis for sample sources to realize precision medicine and translational medicine. The construction of a full-process biobank standardization requires the standardization of the whole process from the application before the collection of biological samples, the review of the ethics committee, the informed consent, to the collection, processing, storage, packaging, use, transportation and destruction of the samples. The formulation and implementation of [13]. In the later construction of biobanks in my country, the construction of biobanks should be carried out in strict accordance with the ISO 20387:2018 standard, and fully learn from the successful experience and standards of international sample bank construction, such as "ISBER Best Practices", Canadian Tissue Bank Collaboration Network The "Standard Operating Procedures of the Sample Library", etc. At the same time, it is also necessary to form a complete set of standardized construction procedures for biological sample banks according to my country's unique national conditions and regional characteristics, and establish a reward and punishment mechanism to strengthen the government's investment in high-quality biological sample banks. , rectify within a time limit, and conduct interviews if the rectification is not in place, correspondingly reduce the investment in the sample library that year, make it meet the standards, and further improve the quality of my country's biological sample library construction.

3.2 Establish a biological sample discipline and cultivate high-quality professionals

Discipline development and talent training go hand in hand. The rapid development of a new discipline is inseparable from senior professional talents. Similarly, the cultivation of senior professional talents requires the development of disciplines. Biobank has a history of more than 20 years in my country, but so far it has not formed a professional discipline, which makes the development of sample bank personnel also greatly restricted. There is an urgent need for BBCMBA and industry experts and scholars to reach a consensus, strive to create a new discipline in the Ministry of Education, promote the development of biosamples, train high-quality full-time sample bank staff, promote the development of translational medicine and precision medicine, and promote the healthy development of all mankind . Each biobank should also strengthen the internal and external training of its staff, encourage further study in excellent biobanks at home and abroad, and improve their professional and technical level.

3.3 Integrate and share sample resources to improve sample utilization

The sharing of biological sample information is the mainstream direction of the current development of biological sample banks. As early as 2008, the European Union implemented the European Biobank and Biomolecular Resources Research Program, which solved the problems of laws and regulations, funding sources, management models and technical coordination required for the integration of biological samples, and realized the sharing and sharing of sample information. The UK Biobank officially opened all data to researchers around the world in 2017, and is currently the world's largest database of medical biological samples. In 2015, my country launched the precision medicine plan, and it is estimated that 60 billion yuan will be invested in 2030 to develop the precision medicine market and provide a favorable policy environment for the development of biological sample banks [14]. Seize the opportunity of the country to vigorously develop big data platforms and precision medicine, use sample library pre-processing workstations, automated storage systems and automated nucleic acid extraction equipment to build an intelligent biological sample library, so that the quality of biological samples can be guaranteed, the storage is intensive and efficient, and the operation is flexible Convenient, reduce labor costs, operation and maintenance costs, and improve sample utilization. As a big country of human genetic resources, my country should also actively promote the sharing of biological samples, integrate the resources of various biological sample banks, establish a sample information management system, and avoid the generation of "garbage banks" and "dead banks".