Blood Filter to Remove Pathogen Inactivation Compound

描述（由申请人提供）：在美国，每年约有1400万单位的浓缩红细胞输注。为了解决血源性病原体的健康风险，正在开发用于细胞血液制品的病原体减少技术。为了杀灭血液中的微生物，将指定为INACTINE PEN110的杀微生物化合物加入血液中并孵育足够的时间以使病原体灭活。最终的结果是相对不含感染因子但被杀微生物化合物污染的生物组合物。从红细胞浓缩物（RBCC）中去除INACTINE PEN110目前涉及使用自动化细胞洗涤程序广泛洗涤经处理的RBCC。虽然这种方法确实去除了杀微生物化合物，但细胞洗涤程序消耗了大量的试剂和时间。因此，需要一种从经处理的生物组合物中除去带正电荷的杀微生物化合物的更有效的方法。该授权申请的目标是开发一种用于从血液组合物中去除杀微生物化合物PEN 110的血液过滤器。过滤器的开发将允许以更有效和成本效益高的方式去除病原体灭活化学品。除了节省时间和金钱外，过滤器的开发还将使在偏远地区生产安全的输血血液成为可能，这些地区的细胞清洗可能不切实际，包括发展中国家和军事应用。第一阶段计划开发一个“概念验证”原型过滤器将实现以下具体目标：1.根据物理化学特征选择用于过滤器的候选介质。2.评价所选过滤介质的功能性和生物相容性，以确定其在不影响红细胞质量的情况下从红细胞浓缩液中去除PEN110的能力。3.构建符合规定性能规格的“概念验证”原型过滤器。

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.