TITER ON CHIP: ALTERNATIVE TO SRID FOR INFLUENZA VACCINE POTENCY DETERMINATION

描述(由申请人提供)：人们普遍认为，对于裂解疫苗，效力确定通常是一个速率限制步骤。FDA批准的流感血凝素(HA)蛋白疫苗效价的金标准是单径向免疫扩散(SRID)。SRID是一项耗时耗力的分析，通常需要2-3天的时间才能完成，训练有素的分析师至少需要6小时的动手时间。对于每个生产设施，许可证前和许可证后测试的SRID分析成本每年可能超过200万美元。就对季节性流感疫苗开发进程的影响而言，也许更重要的是新的参考抗血清所需时间造成的开发和生产延迟。即使有了参考材料，在推进开发之前，每一轮克隆评估的结果也可能需要几天的等待。总体而言，这一结果是疫苗开发过程中公认的低效一步。如果得到资助， 该项目将产生一种创新的现成产品，消除对参考抗血清的需求。流感芯片滴度产品将通过简化疫苗开发所有阶段的血凝素的量化，使疫苗生产商能够大幅降低成本，标准化结果，并更快地向市场提供流感疫苗，从过程中到原料药，再到三价或四价疫苗配方。

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.