Monitoring System For Vector-Based Influenza Vaccine

描述（由申请人提供）：本II期先进技术SBIR [PA-06-134]提案是对NIAID高优先级流感研究领域通知[NOT-AI-05-013]的回应。为了向卫生官员提供有效防治流感大流行毒株所需的工具，必须开发快速和具有成本效益的疫苗生产方法。该仪器是专门设计用于提供液体中每单位体积“完整”病毒数量的快速计数。虽然疫苗生产方法的优化是一个示例应用，完整病毒的数量是一个有价值的衡量标准，但预计在几分钟而不是几天内进行病毒枚举所节省的时间和成本将对其他几个与病毒相关的领域产生重大影响。支持这一前景的是我们在I期努力期间能够召集的优秀合作者小组，包括来自两家大型疫苗制造商（MedImmune和Novartis）、一家小型尖端疫苗制造商（Protein Sciences Corporation）、一家生物试剂公司（Microbix Biosystems, Inc.）、一家诊断公司（Quidel Corporation）和一所医学院（贝勒大学）的科学家。第一阶段的所有目标都已实现，在许多情况下甚至超过了目标。在第二阶段的工作中，我们将i)设计和构建一个先进的病毒计数器原型，并开发仪器参数设置的自动化方法；ii)与标准方法（如空斑测定法、荧光焦点测定法、透射电子显微镜和实时定量PCR）进行比较，评估仪器的性能；iii)优化病毒CounterTM和检测方法，以便在疫苗生产中使用；iv)对仪器进行β -位点测试。

DESCRIPTION (provided by applicant): This Phase II Advanced Technology SBIR [PA-06-134] proposal is in response to NIAID's Notice of High-Priority Influenza Research Areas [NOT-AI-05-013]. In order to provide health officials with the tools required to efficiently combat a pandemic strain of influenza, it is essential that rapid and cost-effective methods for vaccine production be developed. The proposed instrument is specifically designed to provide a rapid count of the number of "intact" viruses per unit volume in liquid. While optimization of vaccine production methods is an example application for which the number of intact viruses is a valuable measurement, the time and cost savings of virus enumeration within minutes, rather than days, is anticipated to have substantial impact on several other virus-related fields. Support for that outlook is provided by the excellent group of collaborators we have been able to assemble during the Phase I efforts, including scientists from two large vaccine manufacturers (MedImmune and Novartis), a small cutting-edge vaccine manufacturer (Protein Sciences Corporation), a biological reagents company (Microbix Biosystems, Inc.), a diagnostics company (Quidel Corporation), and a College of Medicine (at Baylor). All Phase I objectives were achieved and in many cases exceeded. During Phase II efforts we will i) design and construct an advanced prototype Virus CounterTM and develop automated methods for instrument parameter setup; ii) evaluate instrument performance in comparison with standard methods such as plaque assays, fluorescence focus assays, transmission electron microscopy and real-time quantitative PCR, iii) optimize the Virus CounterTM and assay for utility in vaccine production, and iv) conduct beta-site testing of the instrument. PUBLIC HEALTH RELEVANCE: In order to provide health officials with the tools required to efficiently combat a pandemic strain of influenza, it is essential that rapid and cost-effective methods for vaccine production be developed. The proposed instrument is specifically designed to provide a rapid count of the number of "intact" viruses per unit volume in liquid. While optimization of vaccine production methods is an example application for which the number of intact viruses is a valuable measurement, the time and cost savings of virus enumeration within minutes, rather than days, is anticipated to have substantial impact on several other virus-related fields.