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

基本信息

批准号：
8778575
负责人：
KATHY L ROWLEN
金额：
$ 96.01万
依托单位：
INDEVR, INC.
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-05-15 至 2017-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8778575
关键词：
Accounting Advanced Development Animal Model Antigens Biological Assay Canada Clinical Computer software Custom Data Development Drug Formulations Environment Evaluation FDA approved Feedback Freezing Funding Future Gold Hand Hemagglutinin Hour Image Immune Sera Immunodiffusion Immunoglobulin Fragments Industry Influenza Hemagglutinin Label Letters Licensure Marketing Measures Medicago Methodology Methods National Research Council Nature Pharmaceutical Preparations Phase Plants Procedures Process Production Property Proteins Radial Reagent Route Science Site Staging System Technology Testing Time Training Vaccine Production Vaccines Validation Virus-like particle Work base cost cost effective design efficacy trial flu improved influenza virus vaccine innovation meetings multiple myeloma M Protein nanobodies novel vaccines pandemic disease public health relevance seasonal influenza success vaccine development vaccine efficacy validation studies

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.

描述（由申请人提供）：广泛认为对于分裂疫苗，效力确定通常是限制速率的步骤。 FDA批准的基于流感的血凝素（HA）蛋白质疫苗的“金标准”效力分析是单辐射免疫扩散（SRID）。 SRID是一个时间和劳动密集的测定法，通常需要2-3天才能完成，而训练有素的分析师至少需要6个小时的动手时间。每种生产设施的SRID分析的成本每年都超过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的时间所施加的开发和生产延迟。即使掌握了参考材料，在进行开发之前，每轮克隆评估的等待也可能是几天。总体而言，结果是疫苗开发过程中公认的效率低下步骤。如果资助，该项目将导致创新的货架产品，从而消除了对referece Antisera的需求。片上流感片剂的产品将使疫苗生产商能够大幅降低成本，标准化结果并通过简化疫苗开发的所有阶段的血凝集素的量化，从过程中，从过程中到散装药物到散装药物，再到三价疫苗的疫苗，从而更快地将流感疫苗传递到市场上。