An Investigation Of Major Problems In Biobank Operation And The Proposed Solutions

The concept of biobank was born in the 1990s.A biobank is a repository that collects,processes,stores,and distributes samples of biological materials such as cells,tissues,body fluids,bacteria,viruses,DNA,or RNA,etc.from human,animals,and plants(including endangered species)along with detailed information about each sample,for use in scientific research as well as tremendous medical,industrial,and agricultural applications.Biobanking is defined as the practice of creating organized and standardized large-scale biobanks.In the context of this Ph.D.dissertation,the scope of the investigation is primarily focused on the biobanking of human biospecimens.Over the past 30 years,biobanking has become indispensable for promoting and generating great advances and breakthroughs made in biomedical research as well as clinical diagnosis and treatments including gene therapy,cellular therapy,stem cell transplantation to cure acquired diseases and to correct genetic defects.Biobanks have been developed as critical bio-resource foundations making a great impact on the research and development in regenerative medicine,tissue engineering,personalized medicine,new vaccine or drug development,disease screening,in vitro fertilization,bio-technology development,and conservation of endangered species.With the rapid and extensive establishment of various biobanks around the world,many unexpected problems,challenges,and difficulties in biobanking have followed one after another.This research focused on the following two critical problem categories:(1)the problems in biobanking management and operation(including biobanking management strategy,policy,operating costs,sources of funding,and the exchange of biological samples with big information data,etc.);and(2)the legal and ethical problems in biobanking.The following research methods and approaches were used to achieve in-depth scientific research work throughout the dissertation:(1)systematic and intensive literature survey and investigation through reviewing numerous publications and searching various internet websites,(2)performing important case studies and analyses,(3)field visits and onsite investigations to the biobanks(including the author’s three-month internship research work in the Shenzhen BGI Corporation and the China National Gene Bank),(4)conducting online questionnaire surveys and statistical analyses about biobank professionals’ status and management in China,(5)comparative studies on the operating experience,composition,policy,legal and ethical issues,management structure,and financial sustainability of various advanced biobanks in different countries.Based on the research work,the evidence-based countermeasures,solutions,and suggestions to solve the problems above were proposed and developed.The major investigations and contributions of the dissertation are as follows:(1)Conducting comprehensive literature review and making intensive reports on the biobanking significances,the biobank developmental history,and the critical problems and challenges facing to the biobanking operation and practice.(2)Investigating important problems in biobanking management,operation,finance,and policy,in general,and focusing on an urgent world crisis problem,in particular(i.e.,biobanking of biological samples with the novel coronavirus/COVID19 virus that is raging all over the world.),exploring and developing new solutions for the virus sample management specifications,sample-associated big data management,and international research collaborations.Biobanking of the COVID-19 biospecimens is also an excellent representative case study of general biobanking operation and management.Research results and solutions generated from the COVID-19 biospecimens biobanking will make great impacts and contributions not only to the control and treatment of the COVID-19 pandemic but also to the general biobanking operation,management,and advancement.Based on the nationwide questionnaire survey to Chinese biobank professionals,the solutions and countermeasures to address the "people-oriented" management problems are developed.From the overall studies above,the biobanking centralization and biobanking full automation were identified and determined to be two effective approaches to not only increase the biobanking quality and efficiency but also decrease the biobank operation cost.(3)Investigating the important legal and ethical issues involved in the operation of biobanks(including:the right to sign the informed consent of the sample donor,the legal ownership of the donated biological samples,the ownership of intellectual properties generated from the research using the biological samples,the patentability of genetic information or inventions,the copyright of the published genome sequence,the right of sample donor to know the whereabouts of the sample after the planned scientific research is completed and the donor right to consent for their samples to be used again for other different research activities,the privacy of sample donor and related economic returns,the relationship between the biobank and intellectual properties generated from research work using the biospecimen provided by the biobank,etc.)and a number of internationally renowned cases,based on which the countermeasures and suggestions to solve these legal and ethical problems were proposed and developed.(4)Comparatively studying the construction and management models of four major National Gene Banks(the gene bank is the most sophisticated and complex biobank in terms of its construction scale,technology,operation,and management)with an introduction of the Svalbard Seed Bank.Especially,a full range of detailed research has been conducted on Chinese National Gene Bank(the youngest national gene bank in the world,established in 2016 in Shenzhen,China).The advanced operation and management system of Chinese National Gene Bank and its unique structure of the "three repositories and two platforms" have more successfully solved the three major problems encountered by biobanks all over the world,i.e.,"the insufficient operating funds","the shortage of biological samples",and "the limited usage of biobanking samples and their information in scientific research,medical treatment,as well as industrial and agricultural innovation and development." During the past five years,Chinese National Gene Bank has made significant contributions to the research and development of biotechnology in China and the world.Based on the above-mentioned research,the author proposed a further optimized structure,composition,functionality,and operating model for a modern national biobank.(5)Facing the core difficulties in the exchange and sharing of biobanking specimen and information for research collaborations and applications,the existing political,humanistic,financial,and legal factors affecting the sample-data sharing were revealed and analyzed.Through the case study of the biobanking of new coronavirus(COVID-19)samples and their data exchange,two optimal data exchange platform models were developed,which are conducive and practical for the mutual use and sharing of biological samples and their information at home country or internationally to promote win-win scientific research collaborations.(6)New topics,methods,and prospects for the future advanced biobanking operation and management were discussed and envisioned.In general,this dissertation has investigated the key problems in the current biobank operation and developed the potential countermeasures and solutions to solve the problems.It is expected that the research results and contributions can contribute to the further promotion and improvement of the construction,policy,.management,operation,and standardization of biobanks in China and the world,and can be used to promote scientific and technological innovations and their applications in the fields of biomedicine,industry,and agriculture for the benefit of the whole world.