METHOD FOR STERILIZATION OF HUMAN PLASMA AND PLATELETS

人血浆和血小板的灭菌方法

• 批准号: 2864911
• 负责人: Robert Raulli
• 金额: $ 9.97万
• 依托单位: DORLIN PHARMACEUTICALS, INC.
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-07-15 至 2000-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2864911
• 关键词: antibiotics; antiseptic sterilization; blood banks; human tissue; method development; morphology; plasma; platelets; tissue /cell preparation

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.

本研究旨在开发一种独特的灭菌方法，以延长人血小板的自身寿命并增加其安全性。该方法递送已知在体外杀死广泛的微生物病原体的试剂，包括已知污染血小板浓缩物的细菌物种以及真菌、寄生虫和病毒。致死剂可以从不溶性聚合物中释放出来，该不溶性聚合物可以结合到构成收集袋的塑料中。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。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，增加血小板的保质期。 人血浆将接种人血小板浓缩物的常见微生物污染物，并进行实验以确定具有最佳抗菌效力半衰期的药物。然后在血库处理和储存条件下，在人血小板浓缩物中检测有效化合物。还将确定化合物对血小板生理学的影响的评估。拟议的商业应用：成功开发一种简单、廉价和有效的血浆和血小板浓缩物灭菌工艺，有可能被纳入美国每年生产的大约2000万个血浆和血小板收集容器中。该项目的经济动机是开发灭菌剂，从而延长血小板的保存期。显著延长血小板浓缩物的保质期的能力每年可以为血库节省数百万美元。