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Biobank
http://en.wikipedia.org/wiki/Biobank
A biobank is a type of biorepository that stores biological samples (usually
human) for use in research. Since the late 1990s biobanks have become an
important resource in medical research, supporting many types of contemporary
research like genomics and personalized medicine.
生物樣品資料庫是一種存儲用於研究的生物樣品(通常是人類)的生物儲存庫. 自從1990年代後期, 生物樣品資料庫已成為醫藥研究的一個重要資源,
支持多種類型的當代研究像基因體學以及個體化醫療.
Biobanks give researchers access to data representing larger numbers of people
than could be analyzed previously.
Furthermore, samples in biobanks and the data derived from those samples can
often be used by multiple researchers for multiple purposes.
Many diseases are associated with single-nucleotide polymorphisms, and using
genome-wide association studies to study such biomarkers is often a goal of
biobank research.
Large collections of samples representing tens or hundreds of thousands of
individuals are necessary to conduct these kinds of studies, so researchers may
perform such studies only with large numbers of samples.
Many researchers struggled to acquire sufficient samples prior to the advent of
biobanks. Biobanks have provoked questions on research ethics and medical
ethics, and have provoked widespread discussion.
While viewpoints on what constitutes appropriate biobank ethics diverge,
consensus has been reached that operating biobanks without establishing
carefully considered governing principles and policies could be detrimental to
communities that participate in biobank programs.
生物樣品資料庫給予研究人員能夠存取代表比以前能夠分析的更大人數量的數據.
更進一步的, 在生物樣品資料庫裏的樣品以及從這些樣品獲得的數據, 通常可用由多個研究者用於多種用途中. 許多疾病都與單核苷酸多態性相關聯,
而且使用全基因組關聯研究的方式來研究這樣的生物標誌物, 常常是生物樣品資料庫研究的一個目標.
代表幾萬或幾百萬的個體樣品的收集以進行這類型的研究是必要的.
許多研究者在生物樣品資料庫的完成之前, 很邁力地以獲取足夠的樣品.
生物樣品資料庫已經引發了對科研道德和醫學倫理的問題, 並已引起了廣泛的討論.
雖然對什麼是構成適當的生物樣品資料庫倫理的觀點有所分歧, 已達成共識的是在沒有建立審慎考量的治理原則和政策下運作生物樣品資料庫,
有可能是有害於參與生物樣品資料庫計劃的群體的.
Contents 內容
1. Background 背景
2. Types of biobanks 生物樣品資料庫的類型
3. Biological specimens 生物樣品
3.1 Storage 存儲
3.2 Ownership 所有權
4. Biobank ethics 倫理
5. Governance 治理
5.1 Key organizations 主要組織
5.2 History of biobank governance 生物樣品資料庫的治理歷史
5.3 Economics 經濟學
5.4 Legal cases 法律案件
6. References 參考
7. Further reading 延伸閱讀
8. External links 外部鏈接
Background 背景
Prior to the late 1990s, scientists collected the biological specimens desired
for their experiments themselves, and did not have a particular goal of
routinely sharing their specimens with other laboratories.[1]
When researching genetic disorders, scientists would only consider genes they
already expected to be associated with that disorder —only looking for mutations
in BRCA 1 or BRCA 2 for breast cancer, for example.[1]
By the late 1990s scientists realized that although many diseases are caused at
least in part by a genetic component, few diseases originate from a single
defective gene; most genetic diseases are caused by multiple genetic factors on
multiple genes.[1]
Because the strategy of looking only at single genes was ineffective for finding
the genetic components of many diseases, and because new technology made the
cost of examining a single gene versus doing a genome-wide scan about the same,
scientists began collecting much larger amounts of genetic information when any
was to be collected at all.[1]
在1990年代後期之前, 科學家們自己收集希望用於他們的實驗的生物樣品, 並沒有常規與其他實驗室共享他們的樣品的特定目標[1] .
當研究遺傳性疾病, 科學家們只會考慮他們預計會與該疾病有關聯的基因. 例如乳腺癌方面, 只尋找BRCA1或BRCA2突變[1].
到1990年代後期科學家們意識到, 儘管許多疾病都至少有一個基因組成的參與所引起的, 很少疾病起源於一個單一的基因缺陷,
大多數遺傳疾病是由多個遺傳因素對多個基因引起的.[1]
由於在尋找許多疾病的基因組成時, 僅看著單個基因的策略是沒效的率的, 而且由於新技術使研究單個基因與做一個全基因組掃描的成本大約相同,
當任何基因信息被收集的時候, 科學家們開始收集數量遠大很多的基因信息.[1]
At the same time technological advances also made it possible for wide sharing
of information, so when data was collected, many scientists doing genetics work
found that access to data from genome-wide scans collected for any one reason
would actually be useful in many other types of genetic research.[1]
Whereas before data usually stayed in one laboratory, now scientists began to
store large amounts of genetic data in single places for community use and
sharing.[1]
An immediate result of doing genome-wide scans and sharing data was the
discovery of many single-nucleotide polymorphisms, with an early success being
an improvement from the identification of about 10,000 of these with single-gene
scanning and before biobanks versus 500,000 by 2007 after the genome-wide
scanning practice had been in place for some years.[1]
同時, 技術的進步也使廣泛的資訊共享成為可能為, 所以, 當數據收集好了, 許多做遺傳學研究的科學家發現, 存取為了任何一個原因所收集的全基因組掃描數據
實際上是在許多其它類型的遺傳學研究是有用的.[1]
以前, 數據通常是停留在一個實驗室內, 現在科學家開始在單一地方存儲大量基因數據, 以供群體使用和分享.[1]
一個進行全基因組掃描及數據分享的直接結果是許多單核苷酸多態性的發現, 一個早期的成功的項目是在生物樣品資料庫之前, 用單基因掃描的大約10,000這些的鑑定,
對照於在2007年, 全基因組掃描的做法已沿用了多年之後的500,000, 的改進.[1]
A problem remained; this changing practice allowed the collection of genotype
data, but it did not simultaneously come with a system to gather the related
phenotype data.[1]
Whereas genotype data comes from a biological specimen like a blood sample,
phenotype data has to come from examining a specimen donor with an interview,
physical assessment, review of medical history, or some other process which
could be difficult to arrange.[1]
Even when this data was available, there were ethical uncertainties about the
extent to which and the ways in which patient rights could be preserved by
connecting it to genotypic data.[1]
The institution of the biobank began to be developed to store genotypic data,
associate it with phenotypic data, and make it more widely available to
researchers who needed it.[1]
In 2008 United States researchers stored 270 million specimens in biobanks, and
the rate of new sample collection was 20 million per year.[2]
These numbers are large and representative of a fundamental worldwide change in
the nature of research between the time when such numbers of samples could not
be used and the time when researchers began demanding them.[2]
一個問題仍然存在, 這個變動中的實務允許基因表徵數據的收集, 但它並沒有同時提出一個系統來收集相關的外在表徵數據.[1]
基因表徵數據源自於生物樣品如血液樣品, 而外在表徵數據必須來自於對樣品捐贈者以面談, 身體評估, 審查病史, 或者它可以是很難安排的一些程序.
即使已得到這個數據, 還有有關於將它連接到基因表徵數據時, 病人的權利可以被保存的程度與方式的道德不確定性.[1]
生物樣品資料庫的機構開始發展來存儲基因表徵數據, 與外在表徵數據聯結, 並使其更廣泛地能讓需要它研究人員能取得.[1]
在2008年美國研究人員存儲2.7億樣品在生物樣品資料庫中, 而新樣品的收集速率為每年2千萬.[2]
這些數字是很大的, 而且代表了在這樣的數量的樣品沒辦法被使用的時代, 與研究人員開始提出對它們需求的時代之間, 一個根本的全世界的改變.[2]
Collectively, researchers began to progress beyond single-center research
centers to a next-generation qualitatively different research infrastructure.[3]
Some of the challenges raised by the advent of biobanks are ethical, legal, and
social issues pertaining to their existence, including the fairness of
collecting donations from vulnerable populations, providing informed consent to
donors, the logistics of data disclosure to participants, the right to ownership
of intellectual property, and the privacy and security of donors who
participate.[2]
Because of these new problems, researchers and policymakers began to require new
systems of research governance.[3]
Many researchers have identified biobanking as a key area for infrastructure
development in order to promote drug discovery and drug development.[4]
總體的來說, 研究人員開進展到始超越只有 單-中心 的研究中心, 到一個下一代, 質量上的不同的研究基礎設施.[3]
一些由生物樣品資料庫的出現所帶來的挑戰是 屬於他們的存在的倫理, 法律和社會問題, 包括從弱勢人群收集捐贈的公平性, 提供捐贈者知情的同意書,
數據披露給參與者的邏輯, 知財權的所有權利, 以及, 參與捐贈者的隱私和安全.[2]
由於這些新問題, 研究人員和政策制定者開始要求研究治理的新體系.[3]
許多研究人員已經確定了生物樣品資料庫 是促進藥物的發掘和藥物開發的基礎設施發展的一個關鍵領域.[4]
Types of biobanks
The term "biobank" has been used in different ways[5] but one way is to define
it as "an organized collection of human biological material and associated
information stored for one or more research purposes".[4][6]
Collections of plant, animal, microbe, and other nonhuman materials may also be
described as biobanks but in some discussions the term is reserved for human
specimens.[4]
Biobanks usually incorporate cryogenic storage facilities for the samples.[7]
They may range in size from individual refrigerators to warehouses, and are
maintained by institutions such as hospitals, universities, nonprofit
organizations, and pharmaceutical companies.[7]
生物樣品資料庫的類型 "生物樣品資料庫”這個術語已經以不同的方式用被使用[5],
但是方法之一是將其定義為 "為一個或多個研究目的一個人類的生物材料的有組織收集和相關資訊的存儲.”[4] [6]
植物, 動物, 微生物和其他非人類的材料的集合也可以被稱為生物樣品資料庫, 但在一些討論中, 該術語被保留用於人體樣品.[4]
生物樣品資料庫通常包含樣品的低溫儲藏設施.[7] 他們的尺寸範圍從個別冰箱到倉庫, 並由如醫院, 大學, 非營利組織和製藥公司維護.[7]
Biobanks may be classified by purpose or design.
Disease-oriented biobanks usually have a hospital affiliation through which they
collect samples representing a variety of diseases, perhaps to look for
biomarkers affiliated with disease.[8]
Population-based biobanks need no particular hospital affiliation because they
take samples from large numbers of all kinds of people, perhaps to look for
biomarkers for disease susceptibility in a general population.[9]
Virtual biobanks integrate epidemiological cohorts into a common pool.[10]
Virtual biobanks allow for sample collection to meet national regulations.[11]
Tissue banks harvest and store human tissues for transplantation and research.
As biobanks become more established, it is expected that tissue banks will merge
with biobanks.[11]
Population banks store biomaterial as well as associated characteristics such as
lifestyle, clinical, and environmental data.[11]
生物樣品資料庫可以按用途或設計分類.
疾病導向的生物樣品資料庫通常有一個醫院隸屬關係, 由它們收集代表各種疾病的樣品, 也許是為了尋找隸屬於疾病的生物標誌物.[8]
人群為基礎的生物樣品資料庫不需要特別的醫院聯繫, 因為他們從大量各種人取得樣品, 也許是在一般人群中的尋找疾病的易感性的生物標誌物.[9]
虛擬生物樣品資料庫整合的流行病學群體到一個共同空間.[10] 虛擬生物樣品資料庫允許的樣品採集符合國家規定.[11]
組織資料庫獲取和儲存用於移植和研究的人體組織.
當生物樣品資料庫變得更加確定, 預期組織資料庫將與生物樣品資料庫合併.[11]
人群為基礎的生物樣品資料庫, 儲存生物材料以及相關的特性 , 如生活方式, 臨床和環境數據.[11]
Biological specimens
The collection which a biobank stores and makes available are its specimens
taken by sampling. Specimen types include blood, urine, skin cells, organ
tissue, and other things taken from a body.
The biobank keeps these specimens in good condition until a researcher needs
them to conduct a test, do an experiment, or perform an analysis.
A common test done with specimens is a genome-wide association study and often
specimens which are suitable for this kind of research are suitable for many
others.
生物樣品生物樣品資料庫儲存以及能被取用的收集內容就是採樣的樣品.
樣品類型包括血液, 尿液, 皮膚細胞, 器官組織, 以及其他從身體中取得的東西. 生物樣品資料庫保持這些樣品在良好的狀態,
直到研究人員需要用它們來進行一個測試, 做一個實驗, 或者進行一個分析.
一個用這些樣品的常見的測試是一個全基因組聯結的研究, 而並適合於這方面研究的樣品, 經常適合很多其他的研究.
Storage Biobanks, like other DNA databases, must carefully store and document
access to samples and donor information.[12]
The samples must be maintained reliably with minimal deterioration over time,
and they must be protected from physical damage, both accidental and
intentional.
The registration of each sample entering and exiting the system is centrally
stored, usually on a computer-based system that can be backed up frequently.[12]
The physical location of each sample is noted to allow the rapid location of
specimens.
Archival systems de-identify samples to respect the privacy of donors and allow
blinding of researchers to analysis.[12]
The database, including clinical data, is kept separately with a secure method
to link clinical information to tissue samples.[12]
Room temperature storage of samples is sometimes used, and was developed in
response to perceived disadvantages of low-temperature storage, such as costs
and potential for freezer failure.[12]
Current systems are small and are capable of storing nearly 40,000 samples in
about one tenth of the space required by a −80 °C (−112 °F) freezer.
Replicates or split samples are often stored in separate locations for
security.[12]
存儲生物樣品資料庫, 像其他的DNA資料庫, 必須小心地保存進行樣品和捐贈者信息文件的存取.[12]
樣品必須長期以最小的退化被可靠地維護, 他們必須受到免於受到意外的或故意的物理損壞的保護, 每個樣品進入和退出系統的註冊記錄被集中存儲,
通常是在一個可以經常做備份, 以計算機為基礎的系統[12]
各樣品的空間位置加以標註, 以允許樣品的快速定位. 檔案系統去除樣品的身份識別, 以尊重捐贈者的隱私, 並且可允許研究人員進行盲樣分析[12]
資料庫, 包括臨床資料, 是分開保存的, 以安全的方法連結臨床資訊到組織樣品.[12]
樣品有時被使用室溫儲存, 是為了回應於已知的低溫儲存的缺點而發展出來, 例如成本和冷凍機故障的潛在可能.[12]
目前系統體積小, 而且能在大約是-80℃(-112°F)的冷凍機所需要的十分之一的空間儲存近40000樣品.
為了安全性, 複製或拆分的樣品通常被存儲在不同的位置.[12]
Ownership One controversy of large databases of genetic material is the question
of ownership of samples.
As of 2007, Iceland had three different laws on ownership of the physical
samples and the information they contain.[13]
Icelandic law holds that the Icelandic government has custodial rights of the
physical samples themselves while the donors retain ownership rights.[13]
In contrast, Tonga and Estonia give ownership of biobank samples to the
government, but their laws include strong protections of donor rights.[13]
樣品的所有權問題是遺傳物質的大型資料庫的爭議之一.
在2007年, 冰島對本實物樣品的所有權及其所包含的資訊有三種不同的法律.[13]
冰島法律認為, 冰島政府擁有的實物樣品本身的管養權, 而捐助者保留所有權.[13]
相比之下, 東加和愛沙尼亞把生物樣品資料庫樣品的所有權給政府, 但他們的法律納入捐助者權利的有力的保護.[13]
Biobank ethics
The key event which arises in biobanking is when a researcher wants to collect a
human specimen for research.
When this happens, some issues which arise include the following: right to
privacy for research participants, ownership of the specimen and its derived
data, the extent to which the donor can share in the return of the research
results, and the extent to which a donor is able to consent to be in a research
study.[14]
With respect to consent, the main issue is that biobanks usually collect sample
and data for multiple future research and it is not feasible to obtain specific
consent for any single research.
It has been discussed that one-off consent or a broad consent for various
research purposes may not suffice ethical and legal requirements.[15]
生物樣品資料庫倫理
生物樣品資料庫的關鍵事件的引起, 是當一個研究者想收集進行研究的人體樣品.
當發生這種情況, 它會出現一些問題包括：研究參與者的對於隱私的權利, 試樣及其派生數據的擁有權, 捐贈者在該研究成果可以分享回報的程度, 以及在一項研究中,
一個捐贈者能夠同意的程度[14].
關於同意權, 主要的問題是, 生物樣品資料庫的樣品和數據通常是為多重未來的研究而收集, 而為了取得任何單一的研究的同意權是不易實行的.
已經討論了一次性同意權或用於各種研究用途的廣泛同意權, 可能無法滿足倫理和法律的需求.[15]
Governance
Guidelines for human subject research
Biobanks need ethical oversight from an independent reviewer and the governance
process is intended to be public.
For many types of research, and particularly medical research, oversight comes
at the local level from an institutional review board.
Institutional review boards typically enforce standards set by their country's
government.
To different extents, the law used by different countries is often modeled on
biobank governance recommendations which have been internationally proposed.
There is no internationally accepted set of governance guidelines which are
designed to work with biobanks.
Biobanks typically try to adapt to the broader recommendations of guidelines
which are internationally accepted for human subject research, and use changing
guidelines as they become accepted.
治理
人類課題研究的指引
生物樣品資料庫需要由一個獨立評審者的倫理監督, 而且治理的程序是要被公開的.
對於許多類型的研究, 特別是醫學研究, 監督來自於在地方層級機構的審查委員會.
機構的審查委員會通常由執行自己國家的政府制定的標準.
不同程度上, 不同國家所用的法律, 往往是仿照已經在國際上提出的生物樣品資料庫的治理建議.
沒有一個國際公認為用於生物樣品資料庫而設計的治理指引的集合.
Key organizations
Some examples of organizations which participated in creating written guidelines
about biobanking are the following:[5]
主要組織
一些參與創造生物樣品資料庫有關的書面指引的組織的一些例子如下：
World Medical Association,
Council for International Organizations of Medical Sciences,
Council of Europe, Human Genome Organisation,
World Health Organization, and UNESCO.
History of biobank governance
In 1998 the Icelandic Parliament passed the Act on Health Sector Database which
allowed for the creation of a national biobank in that country.
In 1999 the United States National Bioethics Advisory Commission issued a report
containing policy recommendations about handling human biological specimens.[2]
In 2005 the United States National Cancer Institute founded the Office of
Biorepositories and Biospecimen Research so that it could have a division to
establish a common database and standard operating procedures for its partner
organizations with biospecimen collections.[2]
In 2006 the Council of the European Union adopted a policy on human biological
specimens which was novel for discussing issues unique to biobanks.[2]
生物樣品資料庫管理的歷史
1998年, 冰島議會通過 "在衛生部門資料庫法案", 允許其國家的一個國家生物樣品資料庫的創立.
1999年, 美國國家生物倫理學顧問委員會發布一個包含有關處理人體生物樣品的政策建議的報告.[2]
2005年, 美國國家癌症研究所成立生物儲存庫和生物樣品研究辦公室, 以便它能有一個部門來為有生物樣品收集的夥伴組織, 建立共用的資料庫和標準作業程序.[2]
2006年, 歐盟理事會通過了一個關於人類的生物樣品的政策, 這是對於生物樣品資料庫問題的專門討論的全新的.[2]
Economics
Researchers have called for a greater critical examination of the economic
aspects of Biobanks, particularly those facilitated by the state.[16]
It has been noted that national biobanks are often funded by public/private
partnerships, with finance provided by any combination of national research
councils, medical charities, pharmaceutical company investment and biotech
venture capital.[17]
In this way national biobanks enable an economic relationship mediated between
states, national populations, and commercial entities.
It has been illustrated that there is a strong commercial incentive underlying
the systematic collection of tissue material.
This can be seen particularly in the field of genomic research, where population
sized study lends itself more easily toward diagnostic technologies rather than
basic etiological studies,[18] thus emphasizing risk factors and capitalizing on
preventative measures.
Considering the potential for substantial profit, researchers Mitchell and
Waldby[16] argue that because biobanks enroll large numbers of the national
population as productive participants, whom allow their bodies and prospective
medical histories to create a resource with commercial potential, their
contribution should be seen as a form of “clinical labor" and therefore
participants should also benefit economically.
經濟學研究人員已經對於生物樣品資料庫的經濟學面向的更多更重要的檢查提出呼籲, 特別是那些由國家促成的.[16]
已有指出, 國家生物樣品庫經常是由公共/私營夥伴關係資助, 其財政是由國家研究理事會, 醫療慈善機構, 製藥公司的投資和生物技術創投等任意組合.[17].
以這樣的方式, 國家生物樣品資料庫施行一個介於國家, 民族群體, 和商業實體之間的經濟關係. 這樣的國家生物樣品資料庫啟用的經濟關係國家, 民族的人群,
和商業實體之間的中介.
這已經說明, 在這有系統的組織材料收集下, 有潛在強大的商業動機. 這特別是在基因體學研究領域可以看出來, 在這方面, 人口規模的研究本身更容易傾向於診斷技術,
而不是基本的病因學研究 [18], 所以強調危險因子, 並且投資在預防方法上.
考慮到可觀利潤的潛力, 研究人員Mitchell和Waldby[16]認為, 由於生物樣品資料庫採用了大量的全國人口為生產力的參與者,
他們允許他們的身體和具前瞻性的病史以建立具有商業潛力的資源, 他們的貢獻應該被視為“臨床勞動", 因此參與者的應該在經濟上獲益.
Legal cases
Biobanks by their nature store specimens from human bodies.
There have been cases when the ownership of stored specimens has been in dispute
and taken to court.
Here are some examples of such cases:
法律案件
生物樣品資料庫就其本質進行人體樣品的儲存. 曾有些情況下, 保存樣品的所有權一直存在爭議, 並訴至法院.下面是這種情況的一些例子：
Moore v. Regents of the University of California
Greenberg v. Miami Children’s Hospital Research Institute
Compound management
http://en.wikipedia.org/wiki/Compound_management
Drug discovery depends on methods by which many different chemicals are assayed
for their activity.
These chemicals are stored as physical quantities in a chemical library or
libraries which are often assembled from both outside vendors and internal
chemical synthesis efforts.
These chemical libraries are used in high-throughput screening in the drug
discovery hit to lead process.[1]
The chemical libraries in larger pharmaceutical companies are a critical part of
the discovery process. These chemicals are stored in environmentally controlled
conditions in small or large containers, often labeled with codes that pass back
into a database.
Each chemical in the storage bank must be monitored for shelf life, quantity,
purity and other parameters, and its banked location.
化合物樣品管理
藥物發掘 依賴於測定許多不同的化學品的活性的各種方法.
這些化學品以物質數量被存儲於化學品儲存庫, 或則是被存儲於經常是從外部供應商和內部化學合成的努力兩者所組成的儲存庫.
這些化學品儲存庫被使用在 藥物發掘 的活性化合物(hit compound)到先導化合物(lead compound)的高通量篩選中.[1]
在大型製藥公司的化學品儲存庫是新藥發現過程的一個重要組成部分.
這些化學物質被存儲在受控制的環境條件下的或大或小的容器, 通常標示有傳回數據資料庫的代碼.
每一個化學品儲存庫的化學品必須進行其保質期, 數量, 純度, 及其他參數以及其 監控儲存位置的監控.
In some companies, the compounds can also include biological compounds, such as
purified proteins or nucleic acids.
The management of these chemical libraries, including renewal of outdated
chemicals, databases containing the information, robotics often involved in
fetching chemicals, and quality control of the storage environment is called
Compound Management or Compound Control.
Compound Management is often a significant expense, as well as career for one or
more individuals who manage a chemical library at a research site.[2]
There are many books and journal articles devoted entirely or in part to
compound management.[3]
It has become a critical technological component for high-throughput screening
and chemical genomics.
There are great challenges to be faced in the necessity of compound management,
which are being surmounted by concerted efforts in the public and private
domain.[4]
在一些公司, 這些化合物還可以包括生物化合物, 例如純化的蛋白或核酸.
這些化學品儲存庫的管理, 包括含有已過期化學品及含有此資訊的資料庫的更新, 經常參與存取化學品的機器, 以及存儲環境的品質管制,
被稱為化合物樣品管理或化合物控管.
化合物樣品管理往往是一個顯著的費用, 例如一個或多個管理一個研究單位的化學品儲存庫的個人職業生涯.[2]
有許多書籍和雜誌文章全部或部分致力於化合物樣品管理.[3]
它已成為高通量篩選和化學基因體學的重要技術組成. 化合物樣品管理的必要性有很大的挑戰, 目前在公共和私人領域正在共同努力克服.[4]
In 2008, authors at the National Institutes of Health's Chemical Genomics Center
have released a paper showing the necessity of a highly automated, reliable and
parallel compound management platform, in order to serve over 200,000 different
compounds.[5]
In short, Compound Management requires inventory control of small molecules and
biologics needed for assays and experiments, especially in high-throughput
screening. It utilizes knowledge of chemistry, robotics, biology, and database
management.
The manager must also be acutely aware of safety standards in the handling and
storing of radioactive, volatile, flammable and unstable compounds.
Often, in large pharmaceutical companies, the chemical and biological compounds
contained in compound libraries can number in the millions, making compound
management and compound control important contributors to research and drug
discovery.
在2008年, "國家機構的健康的化學基因組中心" 的作者已經發布了一篇論文, 展示了高度自動化的, 可靠的和並行的化合物樣品管理平台的必要性,
以服務超過200,000種不同的化合物.[5]
簡短來說, 化合物樣品管理要求對於需要做分析和實驗的小分子和生物製劑的庫存控制, 尤其是在高通量篩選.
它用到化學, 機器人, 生物和資料庫管理方面的知識.
管理人員也必須敏銳地注意到在處理及儲存放射性的, 揮發, 易燃, 以及不穩定化合物的安全標準.
通常, 在大型製藥公司, 化學品儲存庫中所包含的化學和生物化合物可在數達百萬, 使得化合物樣品管理和化合物控制成為研究和藥物的發掘的重要貢獻者.
Outsourcing
Because of the significant expenses and infrastructure required for accurate
compound management (space requirements, robotics, IT support, analytical
support, etc.) many companies choose to outsource this function to a company
that specializes in this arena.
It is important to work with a company that has significant experience in
compound management due to the complexity of tracking not only inventory data,
but also compound location, storage conditions, and compound integrity.
This experience also is of paramount importance when knowing how to
appropriately deal with the wide array of materials handled including, solids,
liquids, volatile materials, sticky solids, oils, and gums as well as hazardous,
flammable, hygroscopic and toxic compounds.
外包
由於化合物樣品管理的顯著費用以及精確的化合物樣品管理所需要的基礎設施(空間的要求, 機器人, IT支援, 分析支援等),
許多公司選擇外包此功能給一個專門在這個領域的公司.
與一個不僅包括庫存數據追蹤的複雜性, 也包括化合物的定位, 儲存條件和化合物的完整性等, 有顯著化合物樣品管理經驗的公司工作是很重要的.
當需要知道如何妥善處理範圍廣泛材料時, 包括固體, 液體, 揮發性材料, 粘性固體, 油和樹膠以及有害, 易燃, 吸濕性及有毒化合物, 這方面的經驗是最重要的.
Customers can specify not only the quantity of material but also the exact vial
and cap or plate for their specific application.
The service provides enormous savings from a time perspective as researchers do
not spend their valuable time on weighing hundreds of compounds or getting them
into the correct format for their assay.
It also dramatically reduces disposal costs since the exact amount of material
required can be ordered rather than needing to order e.g. 100 g of material when
only 0.1 g is needed for the experiment.
The high throughput analytical chemistry component of the company allows rapid
validation that compounds are the correct material at the desired purity.
While ASDI's storage conditions minimize degradation, customers may use this
service to validate that the material they sent to ASDI originally was correct
and pure.
Subsequently the service allows re-evaluation of compounds that may have
decomposed during long term storage.
The purification services complement the analytical services by allowing cost
effective, environmentally friendly recovery of partially degraded reactive
intermediates and HTS compounds at a fraction of the cost of synthesizing or
purchasing these materials.
客戶不僅能夠針對其特定的應用, 指定的材料的數量, 也精確切指定小瓶和瓶蓋.
從時間的觀點來看, 這服務提供了大量的節省, 因為研究人員不用花費他們寶貴的時間在稱量達數百種化的合物或則或是用來讓它們成為進行分析的正確的格式.
這也大大降低了廢棄物處理成本, 因為所需材料的精確數量可以訂購, 而不需要訂購, 如100克, 當需實驗只需要0.1克物質.
公司的高通量分析化學部份, 允許快速驗證該化合物是正確的材料及所需的純度.
雖然ASDI的貯存條件盡量減少了降解, 用戶可以使用這個服務來驗證它們發送到ASDI的材料原本是正確的, 純的. 因而,
這個服務允許在長期儲存時可能已經分解的化合物的再評估.
純化服務, 以合成或購買這些材料成本的一小部分部, 允許有成本效益地, 環境友善地回收部分降解的活性中間體及高通量篩選化合物的方式, 補充了分析服務.
Conferences
There are several conferences related to compound management.
The best known is Compound Management & Integrity[6] although many chemistry and
pharmaceutical conferences include talks or specific sections on the topic.
協會
有幾個與化合物樣品管理相關的幾個協會.
最有名的是 "化合物樣品管理及完整性"[6], 雖然許多化學和製藥協會有包含了這個主題的討論跟專題部份.
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