SBIR PHASE 1 TOPIC 43

SBIR 第一阶段主题 43

• 批准号: 8355390
• 负责人: TREVOR CASTOR
• 金额: $ 14.94万
• 依托单位: APHIOS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-06-15 至 2011-12-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8355390
• 关键词: Blood; Blood Platelets; Cell membrane; Contractor; Erythrocytes; FDA approved; In Situ; Light; Medicine; Methodology; Methods; Methylene blue; Plasma; Risk; Screening procedure; Small Business Innovation Research Grant; Solvents; System; Transfusion; Ultraviolet Rays; Virus; pathogen; transmission process

The contractor will identify methodologies for broad spectrum inactivation of pathogens in red blood cell concentrates(RBCC). RBCCs are the main components of blood used in transfusion medicine, yet currently there are no FDAapproved methods for broad spectrum pathogen inactivation for RBCCs; instead, the risk of transfusion associatedpathogen transmission is reduced by screening the transfused blood for specific pathogens. Solvent-detergentmethod, currently approved by FDA for plasma, is active against only enveloped viruses and cannot be used forRBCCs since the RBCCs have a functional plasma membrane. The use of photodynamic compounds such aspsoralens and methylene blue in conjunction with UV light is approved for plasma and platelets in several Europeancountries but the lack of transparency of RBCCs to UV light can pose special challenges to successful and consistentpathogen inactivation in that system.

承包商将确定红细胞浓缩物（RBCC）中病原体广谱灭活的方法。 RBCC是输血医学中使用的血液的主要成分，但目前FDA还没有批准对RBCC进行广谱病原体灭活的方法；相反，通过筛查输血中的特定病原体来降低输血相关病原体传播的风险。目前 FDA 批准用于血浆的溶剂洗涤剂方法仅对有包膜病毒有效，并且不能用于 RBCC，因为 RBCC 具有功能性质膜。在一些欧洲国家，使用光动力化合物（如补骨脂素和亚甲蓝）与紫外线结合用于血浆和血小板已被批准，但 RBCC 对紫外线缺乏透明度可能对该系统中成功且一致的病原体灭活带来特殊挑战。