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，对于分离疫苗，效价测定通常是一个限速步骤。FDA批准的流感血凝素（HA）蛋白疫苗效价测定的“金标准”是单径向免疫扩散（SRID）。SRID是一种时间和劳动密集型分析，通常需要2-3天才能完成，训练有素的分析人员至少需要6小时的动手时间。每个生产设施每年用于许可证前和许可证后测试的SRID分析费用可能超过200万美元。就对季节性流感疫苗开发进程的影响而言，可能更重要的是由于新的参考抗血清所需时间而造成的开发和生产延迟。即使有参考资料在手，在进行开发之前，每一轮克隆评估的等待结果可能需要几天时间。总的来说，结果是疫苗开发过程中公认的低效步骤。如果资助,

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.