METHOD FOR INACTIVATION OF BACTERIA IN PLATELET PRODUCTS

SBIR第一阶段项目的重点是开发一种灭活人血小板产品中细菌的新方法。从而提高安全性并延长产品的保存期限。目前，美国的标准做法是在五天后丢弃未使用的血小板，以减少细菌污染的风险。即使有目前的保障措施，据估计，多达1%的血小板输注液被细菌污染，导致患者败血症，有时导致死亡。由一个独立实验室进行的初步测量表明，科学研究实验室的专有工艺显示出解决这些问题的希望。第一阶段的实验将确定SRL的过程如何将储存的血小板中的细菌数量减少到安全水平，以及血小板的存活情况。这个过程将有几个有益的应用。直接的好处将是减少由细菌引起的疾病和死亡人数。另一个好处是可能延长血小板产品的保质期。第一阶段将确定这种方法的有效性。第二阶段将包括可商业化的完整系统的工程设计和在实验室动物中测试该方法。拟议的商业应用：这项研究的商业应用将是灭活储存在美国血库中的血小板产品中的细菌，从而减少输血引起的疾病和死亡的数量。另一个好处可能是血小板储存时间可能从5天延长到7天，从而降低收集和处理成本;这将导致每年净节省超过7000万美元，仅在美国。

This SBIR Phase I project is focused on developing a new method for inactivating bacteria in human blood platelet products. thereby improving safety and extending product shelf life. Currently, standard practice in the U.S. is to discard unused platelets after five days to reduce the risk of bacterial contamination. Even with present safeguards, it has been estimated that as many as 1% of platelet infusions are contaminated with bacteria that cause sepsis in the patient, sometimes resulting in death. Preliminary measurements performed by an independent laboratory indicate that Science Research Laboratory's proprietary process shows promise for addressing these problems. Phase I experiments will determine how well SRL's process reduces the number of bacteria to a safe level in stored platelets and how well the platelets survive. This process would have several beneficial applications. The immediate benefit would be to reduce the number of illnesses and deaths caused by bacteria. A further benefit would be the possible extension of the shelf life of platelet products. Phase I will determine the efficacy of this method. Phase II will include the engineering design of a complete system that can be commercialized and the testing of this method in laboratory animals. PROPOSED COMMERCIAL APPLICATIONS: The commercial application for this research will be the inactivation of bacteria in platelet products that are stored in blood banks in the U.S., thereby reducing the number of transfusion-induced illnesses and deaths. Another benefit may be the possible extension of platelet storage time from 5 days to 7 days, thereby reducing collection and disposal costs; this would result in net savings of more than $70 million dollars annually, in the U.S. alone.