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

描述（由申请方提供）：普遍认为，对于裂解疫苗，效价测定通常是一个限速步骤。FDA批准的基于流感血凝素（HA）蛋白的疫苗的“金标准”效价测定是单向放射免疫扩散（SRID）。SRID是一种时间和劳动密集型测定，通常需要2-3天才能完成，并且由训练有素的分析员进行至少6小时的动手时间。对于每个生产设施，许可前和许可后测试的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过程的影响而言，可能更重要的是新参考抗血清所需的时间造成的开发和生产延迟。即使手头有参考材料，在向前发展之前，每一轮克隆评估等待结果的时间也可能是几天。总的来说，这是疫苗开发过程中公认的低效步骤。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要。Flu Titer-on-Chip产品将使疫苗生产商能够大幅降低成本，标准化结果，并通过在疫苗开发的所有阶段简化血凝素的定量来更快地将流感疫苗推向市场，从过程中到散装药物物质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.