VIRAL INACTIVATION OF INTRAVENOUS IMMUNOGLOBULIN (IVIG)

这项建议的长期目标是制定一项切实可行的 用于灭活血液衍生产品中病毒的方法，静脉注射 免疫球蛋白(IVIG)，适用于制造环境。 这种方法代表着治疗的重大商业机会 被HIV等致病病毒污染的血浆衍生品， 丙型肝炎(丙型肝炎)、甲型肝炎(甲型肝炎)和微小病毒BL9。非封套的 细小病毒BL9和甲型肝炎病毒等病毒对多种 物理和化学失活程序。病毒灭活是 由一类新的试剂INACTINE(TM)化合物实现，这些试剂是 对核酸的选择性高于蛋白质或其他生物分子。 初步结果表明，这些化合物可以灭活。 病毒的速度高达3log10/小时，对包膜和 无包膜病毒。在本提案中，一系列INACTINE(TM) 我们将对化合物进行筛选，从中选出活性最高的化合物 静脉注射免疫球蛋白灭活效果的优化。失活动力学将是 为艾滋病毒定义，为人类细小病毒BL9和丙型肝炎病毒模型病毒定义。 将在以下条件下分析IVIG的物理和生物学特性 病毒灭活的最佳条件。这项研究将使 我的综合计划的阶段，以制定有效和 实用产品，具有二期SBIR支持。 建议的商业应用： INACTINE(TM)化合物将用于灭活病原体 制造环境中的血浆衍生品中的病毒。方法 将首先与IVIG一起开发，然后应用于其他衍生品。 目前的信息表明，制造的成本 INACTINE(商标)使这项技术的使用非常划算。

The long-term objective of this proposal is to develop a practical method for inactivating viruses in a blood-derived product, intravenous immunoglobulin (IVIG), that is applicable to the manufacturing setting. The method represents a significant commercial opportunity for treating plasma derivatives contaminated with pathogenic viruses like HIV, hepatitis C (HCV), hepatitis A (HAV) and parvovirus Bl9. Non-enveloped viruses like parvovirus Bl9 and HAV are quite resistant to a variety of physical and chemical inactivation procedures. viral inactivation is achieved by a novel class of agents, INACTINE(TM) compounds, that are highly selective for nucleic acid over proteins or other biomolecules. Preliminary results have established that these compounds can inactivate viruses at up to 3 log10/hr and are effective against both enveloped and non-enveloped viruses. In this proposal, a series of INACTINE(TM) compounds will be screened and the most active one selected for optimization of inactivation in IVIG. inactivation kinetics will be defined for HIV and for model viruses for human parvovirus Bl9 and HCV. Physical and biological properties of IVIG will be analyzed under optimal conditions for viral inactivation. This research will set the stage for a me comprehensive program to develop an effective and practical product, with Phase II SBIR support. PROPOSED COMMERCIAL APPLICATION: INACTINE(TM) compounds will be useful for inactivating pathogenic viruses in plasma derivatives in a manufacturing setting. The method will be developed first with IVIG and then applied to other derivatives. Current information indicates that the cost of manufacture of INACTINE(TM) lends itself to very cost-effective use of the technology.