CBCSLC TASK ORDER FOR THE NCI CHEMICAL BIOLOGY CONSORTIUM, TO# 1 12 MONTH TASK ORDER BASE
CBCSLC TASK ORDER FOR THE NCI CHEMICAL BIOLOGY CONSORTIUM, TO# 1 12 MONTH TASK ORDER BASE
批准号:
9564742
负责人:
CHARLES JOHNSON
金额:
$26.74万
依托单位:
--
依托单位国家:
美国
项目类别:
财政年份:
2015
资助国家:
美国
项目状态:
已结题
起止时间:
2015-09-30 至 2018-09-29
关键词:
ArchivesBiologyBusinessesCharacteristicsChargeChemical StructureChemicalsChinaCollectionContractorContractsCustomDataDatabasesDescriptorDimethyl SulfoxideDistributional ActivityDiversity LibraryDocumentationDry IceEnsureEquipmentEquipment and supply inventoriesFilmGovernmentHigh Pressure Liquid ChromatographyIndiaIndividualInformaticsInstitutesInternationalIonsLibrariesLifeMaintenanceMass FragmentographyMethodsMolecularMonitorPowder dose formPropertyQuality ControlRecording of previous eventsRegulationResearch InfrastructureResearch PersonnelSamplingShippingShipsSolidSolventsSpecific qualifier valueStructureTubeUpdateVial devicebasecostcost effectivedesignfallsflexibilityhigh throughput analysisinstrumentliquid chromatography mass spectrometrymemberplanetary Atmospherequality assurancesample collectionscreeningsolid solution
中文摘要
所列任务将在整个合同有效期内持续执行。
A.储存-在确保最佳稳定性和纯度的条件下,将大约135,000个CBCSLC化合物文库储存在适当的设施中,以及与维护相关基础设施相关的后台任务。图书馆的藏品被保存为混合的:1)4dram瓶装的整洁固体/薄膜,2)矩阵管中的工作溶液存储和3)384孔微滴定板。承包商应有能力将所有样品在-78℃、-20℃和0°C的惰性气氛中长期保存,以符合成本效益的方式保持质量。标准储存条件为-20°C,在惰性气氛中使用DMSO作为溶液溶剂。应具有足够的存储空间和灵活性,以适应存储类型组合的变化。承包商应提供储存、维护和跟踪库存所需的所有专业知识、设备和设施。储存和搬运应遵守所有适用的地方、州和联邦法规。-根据本合同供应或购买的任何和所有化合物,无论是以固体、溶液或电镀的形式储存,在合同有效期内均为政府财产。承包商应将这些化合物转移到后续合同中,如有合同签发,或按照合同官员或其代表的指示将化合物转移到适当的设施。请参阅本SOW的K节-
B.质量控制-承包商应按照COR的要求进行快速、低通量的化学纯度分析(如LC/MS、高效液相色谱和/或核磁共振)。预计这将涉及每年50-250个样本。承包商应拥有仪器和其他设备的持续质量保证计划。QC要求(纯度和特性)应包括但不限于通过GC-MS或LC-MS进行高通量分析的能力,并通过显示指定的纯度(根据COR的规定)将结果解释为合格或不符合QC标准。主要分析方法为LC-MS和/或GC-MS。当这些方法不适用时,承包商应有能力进行常规的1H-核磁共振纯度分析。预计1%的样品将需要1H-核磁共振分析。如果没有通过MS观察到的分子离子或与结构不一致的核磁共振谱来确认结构,则认为是失败的。
C.分发-承包商应有能力根据COR的要求向CBC筛查中心和外部调查人员运送板式套装(如多样性图书馆、重点套装和一次性套装)。承包商应有能力使用国内装运的“下一工作日”按周装运。承包商还应有能力进行国际运输,包括印度和中国地区。据估计,国际出货量将微乎其微。预计将有10-15个研究所组成CBC,包括5-8个筛查中心。化合物运输的方式应确保内容物的完整性(例如,用干冰包装),并应符合所有适用的联邦、州和地方法规以及国际航运和海关法规。预计每年将有15-20套个人出货量,其中包括现有的图书馆和精心挑选的套装。直接运输成本将通过其联邦快递号码向收件人收取,而与包装相关的成本将由承包商负责。
D.库存监控和回购-承包商应监控和维护足够的化合物库存,包括溶液和干存库,以确保COR规定的所有化合物有足够的阈值数量,以支持筛选需求。当化合物因耗尽或降解而低于最低库存量(例如5毫克)时,承包商应采取一切必要活动,购买足够数量的化合物以补充库存,并经COR批准。预计每年需要补充的样本不超过0.5%。据估计,在合同有效期内,这将是约300种化合物。
E.CBC合成化合物-承包商还应有能力管理CBC成员生成的干粉合成样品。预计在合同有效期内,化合物的数量将是最少的(即50英镑)。样品的管理将涉及接收、登记、库存、储存、分析和分发活动。
F.处置-承包商在处置化学样品、个人防护设备、溶剂和化学污染的小瓶、管子和盘子时,应遵守所有当地、州和联邦法规。
G.信息学和文件-承包商应维护和更新CBCSLC电子数据库,其中包含单独的化学结构、描述符、相关的物理化学数据以及分布和库存信息。承包商的数据库应在功能上与基于Oracle的内部NCI/CBC数据库兼容。承包商应负责定期同步数据库之间的CBC相关信息。此外,承包商应提供档案文件,描述在合同有效期内添加到馆藏中的新图书馆的设计历史、物理化学特征和内容。
英文摘要
The listed tasks will be performed on an on-going basis throughout the contract life.
a. Storage- Storage of the approximately 135,000 compound CBCSLC library in a suitable facility under conditions that ensure optimal stability and purity, along with background tasks related to the maintenance of associated infrastructure. The library collection is maintained as a mix of: 1) 4 dram vialed neat solid/films, 2) working solution stores in Matrix tubes and 3) 384-well microtiter plates. The Contractor shall have the capability to store all samples long-term at -78, -20, and 0°C under inert atmosphere as appropriate for maintaining quality in a cost effective manner. The standard storage conditions are -20°C under an inert atmosphere employing DMSO as a solution solvent. There shall be sufficient storage space and flexibility to accommodate changes in the mix of storage types. The Contractor shall provide all the necessary expertise, equipment, and facilities to store, maintain, and track the inventory. Storage and handling shall comply with all applicable local, state and Federal regulations. – ANY AND ALL COMPOUNDS SUPPLIED OR PURCHASED UNDER THIS CONTRACT, STORED AS SOLIDS, SOLUTIONS OR PLATED, SHALL REMAIN THE PROPERTY OF THE GOVERNMENT THROUGHOUT THE LIFE OF THE CONTRACT. THE CONTRACTOR SHALL TRANSFER THESE COMPOUNDS TO THE FOLLOW-ON CONTRACT SHOULD ONE BE ISSUED OR TRANSFER THE COMPOUNDS TO THE APPROPRIATE FACILITY AS DIRECTED BY THE CONTRACTING OFFICER OR HIS REPRESENTATIVE. See section K of this SOW -
b. Quality Control – The Contractor shall perform rapid, low throughput analyses of chemical purity (e.g., LC/MS, HPLC, and/or NMR) as requested by the COR. It is anticipated that this will involve 50-250 samples annually. The Contractor shall be required to have an on-going Quality Assurance plan for instruments and other equipment. The QC requirement (purity and identity) shall include but is not limited to ability to carry out high throughput analysis by GC-MS or LC-MS and interpret results as passing or failing to meet QC criteria by showing specified purity (as specified by the COR). The primary method of analysis shall be LC-MS and/or GC-MS. When these methods are not suitable the Contractor shall have the capability to routinely perform purity analysis by 1H-NMR. It is anticipated that <1% of samples will require 1H-NMR analysis. Structure not confirmed by lack of observed molecular ion by MS or NMR spectra inconsistent with structure is deemed as failing.
c. Distribution – The Contractor shall have the capability to ship plated sets (e.g. diversity library, focused libraries and single-use sets) to the CBC screening centers and external investigators, as requested by the COR. The Contractor shall have capability to ship on a weekly basis using “next business day” for domestic shipments. The Contractor shall also have the capability to ship internationally including regions in India and China. It is estimated that international shipments will be minimal. It is anticipated that 10-15 institutes will comprise the CBC including 5-8 screening centers. Compound shipments shall be made in such a way as to ensure the integrity of the contents (e.g. packed in dry ice) and shall comply with all applicable federal, state, and local regulations and international shipping and custom regulations. It is anticipated that 15-20 individual shipments will be made annually that include existing libraries and cherry-picked sets. The direct shipping costs will be charged to the recipient through their Fedex number while the cost associated with packaging will be the responsibility of the Contractor.
d. Inventory Monitoring and Repurchase- The Contractor shall monitor and maintain adequate compound inventory, both solution and dry store, to ensure that sufficient threshold quantities, as specified by the COR, of all compounds are available to support screening needs. As compounds fall below threshold inventory (e.g. 5 mg), either by depletion or degradation, the Contractor shall undertake all activities necessary to purchase sufficient quantities of the compound to replenish the inventory upon approval by the COR. It is anticipated that no more than 0.5% of the sample collection will need to be replenished annually. It is estimated that this would be ~300 compounds over the life of the contract.
e. CBC Synthetic Compounds – The Contractor shall also have the capability to manage CBC member generated dry powder synthetic samples. It is anticipated that the number of compounds will be minimal over the life of the contract (i.e. <50). Management of samples will involve receipt, registration, inventory, storage, analysis and distribution activities.
f. Disposal – The Contractor shall comply with all local, state and Federal regulations in the disposal of chemical samples, personal protective equipment, solvents and chemically contaminated vials, tubes and plates.
g. Informatics and Documentation - The Contractor shall maintain and update the CBCSLC electronic database containing individual chemical structures, descriptors, associated physiochemical data along with distribution and inventory information. The Contractor’s database shall be functionally compatible with the internal Oracle-based NCI/CBC database. The Contractor shall be responsible for regularly synchronizing the CBC-related information between the databases. In addition, the Contactor shall produce archival documents that describe the design history, physiochemical characteristics and content of new libraries added to the collection over the life of the contract.
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