TITER ON CHIP: ALTERNATIVE TO SRID FOR INFLUENZA VACCINE POTENCY DETERMINATION
芯片滴度:流感疫苗效力测定中 SRID 的替代方案
基本信息
- 批准号:9520670
- 负责人:
- 金额:$ 39.57万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2017
- 资助国家:美国
- 起止时间:2017-08-01 至 2018-07-31
- 项目状态:已结题
- 来源:
- 关键词:Advanced DevelopmentAnimal ModelAntigensBiological AssayCanadaClinicalComputer softwareCustomDataDevelopmentEnvironmentEvaluationFDA approvedFeedbackFreezingFundingFutureGoldHandHemagglutininHourImageImmune SeraImmunodiffusionImmunoglobulin FragmentsIndustryInfluenza HemagglutininLabelLettersLicensureMeasuresMedicagoMethodologyMethodsNational Research CouncilNaturePharmaceutical PreparationsPhasePlantsProceduresProcessProductionPropertyProteinsRadialReagentRouteScienceSiteStandardizationSystemTechnologyTestingTimeTrainingVaccine ProductionVaccinesValidationVirus-like particleWorkbasecostcost effectivedesignefficacy trialfluimaging systemimprovedinfluenza virus vaccineinnovationmultiple myeloma M Proteinnanobodiesnovel vaccinespandemic diseasepublic health relevanceseasonal influenzasuccessvaccine developmentvaccine efficacy
项目摘要
DESCRIPTION (provided by applicant): It is widely acknowledged that for split vaccines, potency determination is often a rate limiting step. The FDA approved "gold standard" potency assay for influenza hemagglutinin (HA) protein-based vaccines is single radial immunodiffusion (SRID). SRID is a time and labor intensive assay, often requiring 2-3 days to complete and a minimum of 6 hours hands-on time by well-trained analysts. Costs for SRID analysis for both pre-licensure and post-licensure testing can be more than $2 million per year for each production facility. In terms of impact on the seasonal influenza vaccine development process, perhaps even more important are the development and production delays imposed by the time required for new reference antisera. Even with reference materials in hand, the wait for results can be days for each round of clone assessment prior to moving forward in development. Overall, the result is a recognized inefficient step in the vaccine development process. If funded,
this project will result in an innovative off-the shelf product that eliminates the need for referece antisera. The Flu Titer-on-Chip product will enable vaccine producers to dramatically reduce costs, standardize results, and deliver flu vaccines to market faster by streamlining quantification of hemagglutinin at all stages of vaccine development, from in-process to bulk drug substances through to tri- or quadrivalent vaccine formulations.
DESCRIPTION (provided by applicant): It is widely acknowledged that for split vaccines, potency determination is often a rate limiting step. FDA 批准的基于流感血凝素 (HA) 蛋白的疫苗的“金标准”效力测定是单径向免疫扩散 (SRID)。 SRID 是一种时间和劳动力密集型检测,通常需要 2-3 天才能完成,并且需要训练有素的分析师至少 6 小时的实践时间。每个生产设施每年用于许可前和许可后测试的 SRID 分析成本可能超过 200 万美元。就对季节性流感疫苗开发过程的影响而言,也许更重要的是新参考抗血清所需时间造成的开发和生产延迟。即使手头有参考材料,在继续开发之前,每轮克隆评估也可能需要等待数天的时间才能得到结果。总体而言,结果是疫苗开发过程中公认的低效步骤。如果有资助,
该项目将产生一种创新的现成产品,无需参考抗血清。 Flu Titer-on-Chip 产品将帮助疫苗生产商大幅降低成本、标准化结果,并通过简化疫苗开发各个阶段(从加工过程到散装原料药,再到三价或四价疫苗配方)的血凝素定量,更快地将流感疫苗推向市场。
项目成果
期刊论文数量(1)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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KATHY L ROWLEN的其他文献
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{{ truncateString('KATHY L ROWLEN', 18)}}的其他基金
Innovative Optical System for Hemagglutination Assays
用于血凝测定的创新光学系统
- 批准号:
9301443 - 财政年份:2014
- 资助金额:
$ 39.57万 - 项目类别:
INNOVATIVE OPTICAL SYSTEM FOR HEMAGGLUTINATION ASSAYS
用于血凝测定的创新光学系统
- 批准号:
8843351 - 财政年份:2014
- 资助金额:
$ 39.57万 - 项目类别:
TITER ON CHIP: ALTERNATIVE TO SRID FOR INFLUENZA VACCINE POTENCY DETERMINATION
芯片滴度:流感疫苗效力测定中 SRID 的替代方案
- 批准号:
8895830 - 财政年份:2012
- 资助金额:
$ 39.57万 - 项目类别:
TITER ON CHIP: ALTERNATIVE TO SRID FOR INFLUENZA VACCINE POTENCY DETERMINATION
芯片滴度:流感疫苗效力测定中 SRID 的替代品
- 批准号:
8778575 - 财政年份:2012
- 资助金额:
$ 39.57万 - 项目类别:
TITER ON CHIP: ALTERNATIVE TO SRID FOR INFLUENZA VACCINE POTENCY DETERMINATION
芯片滴度:流感疫苗效力测定中 SRID 的替代方案
- 批准号:
8465184 - 财政年份:2012
- 资助金额:
$ 39.57万 - 项目类别:
TITER ON CHIP: ALTERNATIVE TO SRID FOR INFLUENZA VACCINE POTENCY DETERMINATION
芯片滴度:流感疫苗效力测定中 SRID 的替代品
- 批准号:
8394059 - 财政年份:2012
- 资助金额:
$ 39.57万 - 项目类别:
Advanced Microarray Technology for Pathogen Surveillance
用于病原体监测的先进微阵列技术
- 批准号:
7267781 - 财政年份:2006
- 资助金额:
$ 39.57万 - 项目类别:
Advanced Microarray Technology for Pathogen Surveillance
用于病原体监测的先进微阵列技术
- 批准号:
7133510 - 财政年份:2006
- 资助金额:
$ 39.57万 - 项目类别:
Advanced Microarray Technology for Pathogen Surveillance
用于病原体监测的先进微阵列技术
- 批准号:
7476524 - 财政年份:2006
- 资助金额:
$ 39.57万 - 项目类别:
Advanced Microarray Technology for Pathogen Surveillance
用于病原体监测的先进微阵列技术
- 批准号:
7669429 - 财政年份:2006
- 资助金额:
$ 39.57万 - 项目类别:
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