Virally Safe Plasma

病毒安全血浆

• 批准号: 6768578
• 负责人: William Drohan
• 金额: $ 31.95万
• 依托单位: CLEARANT, INC.
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-30 至 2005-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6768578
• 关键词: antiseptic sterilization; attenuated microorganism; biotechnology; blood bank /supply contamination; communicable disease transmission; gamma radiation; human tissue; method development; virus diseases; virus infection mechanism

DESCRIPTION (provided by applicant): The recent transmission of HIV by tested blood and plasma demonstrates the need for viral inactivation technology that can be safely applied to plasma. In Phase I, Clearant demonstrated the feasibility of applying a virucidal dose of irradiation to plasma for transfusion using the Clearant Process TM. On a commercial scale, this will be significantly less expensive than other technologies in development. Clearant proposes to develop methods of utilizing gamma-irradiation to inactivate viruses in single donor units of frozen plasma. The goal is to define and test parameters for irradiation of plasma on a commercial scale to inactivate at least 6xlogl0 of enveloped viruses and 4xlogl0 of non-enveloped viruses while retaining marker protein integrity. Protein recovery and activity will be measured using biochemical techniques. In vivo studies will assess acute toxicity, chronic toxicity, and efficacy of the irradiated plasma when compared to the non-irradiated control. Scale-up will involve preliminary screening of the plasma bag material and development of full-scale irradiation procedures at commercial facilities. Viral inactivation and stability studies will be performed at key milestones during process development. Blood banks will license the technology from Clearant, providing a significant commercial opportunity for all organizations while preventing the spread of viruses

描述（由申请人提供）：最近通过测试的血液和血浆传播艾滋病毒表明需要可安全应用于血浆的病毒灭活技术。在第一阶段，Clearant 证明了使用 Clearant Process TM 对血浆应用杀病毒剂量的辐射进行输血的可行性。在商业规模上，这将比正在开发的其他技术便宜得多。 Clearant 建议开发利用伽马射线照射灭活单个冷冻血浆供体单位中的病毒的方法。目标是定义和测试商业规模的等离子体辐射参数，以灭活至少 6xlogl0 的包膜病毒和 4xlogl0 的非包膜病毒，同时保留标记蛋白的完整性。将使用生化技术测量蛋白质回收率和活性。体内研究将评估经辐照血浆与未辐照对照相比的急性毒性、慢性毒性和功效。扩大规模将涉及血浆袋材料的初步筛选以及商业设施全面辐照程序的开发。病毒灭活和稳定性研究将在工艺开发过程中的关键里程碑进行。血库将获得 Clearant 的技术许可，为所有组织提供重要的商业机会，同时防止病毒传播