METHOD FOR STERILIZATION OF HUMAN PLASMA AND PLATELETS

这项建议是为了开发一种方法，通过一种独特的灭菌方法来延长人类血小板的自我寿命，并增加其安全性。这种方法提供了一种已知的试剂，可以在体外杀死广泛的微生物病原体，包括已知的污染浓缩血小板的细菌种类，以及真菌、寄生虫和病毒。致命剂可以从可并入构成收集袋的塑料中的不溶性聚合物中释放。该制剂迅速分解为正常的生理副产物，因此对患者几乎没有危险。这种方法的成功开发将增加血小板和血浆供应的安全性，并通过抑制微生物生长，延长血小板的保质期。人体血浆将接种人类浓缩血小板的常见微生物污染物，并进行实验以确定具有最佳抗菌效果的半衰期的制剂。然后，在血库处理和储存的条件下，将在人类浓缩血小板中测试有效化合物。对这些化合物对血小板生理影响的评估也将得到确定。拟议的商业应用：一种简单、廉价和有效的血浆和血小板浓缩物灭菌工艺的成功开发，有可能被整合到每一个生产的血浆和血小板收集容器中，在美国每年大约有2000万个。这个项目的经济动机是开发灭菌剂，从而延长血小板的保质期。显著延长浓缩血小板的保质期的能力每年可以为血库节省数百万美元。

This proposal is to develop a method to prolong the self-life and increase the safety of human platelets with a unique method of sterilization. The method delivers an agent known to kill a broad range of microbial pathogens in vitro including bacterial species known to contaminate platelet concentrates, as well as fungi, parasites, and viruses. The lethal agent can be released from an insoluble polymer that can be incorporated into the plastic that comprises the collection bag. The agent breaks down rapidly to normal physiological by-products, and thus presents little danger to the patient. Successful development of this method will increase the safety of the platelet and plasma supply, and by inhibiting microbial growth, increase shelf-life of platelets. Human plasma will be inoculated with common microbial contaminants of human platelet concentrates, and experiments performed to determine agents with optimal half-lives for antimicrobial efficacy. Efficacious compounds will then be tested in human platelet concentrates under blood bank conditions of handling and storage. Assessment of the effects of the compounds on the physiology of platelets will also be determined. PROPOSED COMMERCIAL APPLICATIONS: Successful development of a simple, inexpensive and effective process to sterilize plasma and platelet concentrates has the potential to become incorporated into every plasma and platelet collection container produced, roughly 20 million each year in the US. The economic incentive for this project is to develop agents to sterilize, and thus, prolong platelet shelf- life. The ability to significantly increase shelf-life of platelet concentrates could save blood banks millions of dollars each year.