METHOD FOR STERILIZATION OF HUMAN PLASMA AND PLATELETS

该提案旨在开发一种通过独特的灭菌方法来延长人类血小板的自身寿命并提高其安全性的方法。该方法提供了一种已知可在体外杀死多种微生物病原体的试剂，包括已知会污染血小板浓缩物的细菌种类，以及真菌、寄生虫和病毒。致命剂可以从不溶性聚合物中释放出来，该聚合物可以掺入收集袋的塑料中。该药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。该方法的成功开发将提高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。 将用人血小板浓缩物的常见微生物污染物接种人血浆，并进行实验以确定具有最佳抗菌功效半衰期的制剂。然后将在血库处理和储存条件下在人血小板浓缩物中测试有效化合物。还将确定化合物对血小板生理学影响的评估。拟议的商业应用：成功开发出一种简单、廉价且有效的血浆和血小板浓缩物灭菌工艺，有可能被纳入生产的每一个血浆和血小板采集容器中，美国每年大约有 2000 万个。该项目的经济动机是开发灭菌剂，从而延长血小板的保质期。显着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.