Blood Filter to Remove Pathogen Inactivation Compound

描述（由申请人提供）：在美国，每年大约有1400万单位的红细胞浓缩液输注。为了解决血源性病原体的健康风险，正在为细胞血液制品开发减少病原体的技术。为了灭活血液中的微生物，将一种名为INACTINE PEN110的杀微生物化合物添加到血液中并孵育足够的时间以使病原体灭活。最终的结果是一种相对不含传染因子的生物组合物，但它被杀微生物化合物污染了。从红细胞浓缩物（RBCC）中去除INACTINE PEN110目前需要使用自动细胞洗涤程序广泛清洗处理过的RBCC。虽然这种方法确实去除了杀微生物化合物，但细胞洗涤过程消耗了大量的试剂和时间。因此，需要一种更有效的方法从处理过的生物组合物中去除带正电的杀微生物化合物。这项拨款申请的目标是开发一种血液过滤器，用于去除血液成分中的杀微生物化合物PEN110。该过滤器的开发将使病原体灭活化学物质的去除以更有效和更具成本效益的方式完成。除了节省时间和金钱之外，过滤器的开发还将使生产安全的血液用于输血，这些地区的细胞清洗可能是不切实际的，包括发展中国家和军事应用。开发“概念验证”原型过滤器的第一阶段计划将通过实现以下具体目标来实现：根据物理化学特性选择用于过滤器的候选介质。2. 评价所选滤料在不影响红细胞质量的情况下从红细胞浓缩物中去除PEN110的能力和生物相容性。3. 构建“概念验证”原型过滤器，满足定义的性能规格。

DESCRIPTION (provided by applicant): In the United States, there are approximately 14 million units of red cell concentrates transfused annually. To address the health risks of bloodborne pathogens, pathogen reduction technologies are being developed for cellular blood products. To inactivate microbes in blood, a microbiocidal compound designated as INACTINE PEN110 is added to the blood and incubated for sufficient time to allow pathogen inactivation to take place. The end result is a biological composition that is relatively free of infectious agents, but that is contaminated with a microbiocidal compound. Removal of INACTINE PEN110 from a red blood cell concentrate (RBCC) currently involves washing the treated RBCC extensively using automated cell washing procedures. While this methodology does remove the microbiocidal compounds, the procedure for cell washing consumes significant quantities of reagents and time. Therefore, there is a need for a more efficient method for removing positively charged microbiocidal compounds from treated biological compositions. The goal of this grant application is to develop a blood filter for removal of the microbiocidal compound PEN110 from blood compositions. The development of the filter will allow the removal of the pathogen inactivating chemical to be accomplished in a more efficient and cost-effective manner. Beyond savings of time and money, the development of the filter will enable the production of safe blood for transfusion in remote areas where cell washing can be impractical including developing nations and military applications. The Phase 1 program to develop a "proof of concept" prototype filter will be achieved by accomplishing the following specific aims: 1. Selection of candidate media for use in filter based upon physico-chemical characteristics. 2. Evaluate the functionality and biocompatibility of the selected filter media for its ability to remove PEN110 from red cell concentrates without affecting the quality of the red cells. 3. Construct "proof of concept" prototype filters meeting defined performance specifications.