EFFECT OF VON WILLEBRAND FACTOR ON THE ACTIVITY OF RECOMBINANT FACTOR VIII

血管性血友病因子对重组因子VIII活性的影响

• 批准号: 3811120
• 负责人: WILLIAM FRICKE
• 金额: --
• 依托单位: DIVISION OF BASIC SCIENCES - NCI
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3811120
• 关键词: biological products; coagulation factor VIII; von Willebrand factor

Comparison of potency tests of recombinant FVIII manufactured by Miles and by Baxter in the one and two stage assays and the chromogenic assay indicates an extraordinary degree of both interassay and intro-assay variability. Differences between individual runs of same assays can deviate up to 100% from the labelled potency. Predilution of both products in either albumin or factor VIII deficient plasma also affects the potency, with those samples prediluted in deficient plasma having overall higher values. It is planned to do in vivo half life and recovery studies.

Miles 和 生产的重组 FVIII 的效力测试比较 由 Baxter 进行一阶段和两阶段分析以及显色分析 表明分析间和分析内的非凡程度 可变性。 相同测定的各个运行之间的差异可以 与标签效力的偏差高达 100%。 两种产品的预稀释 在白蛋白或因子 VIII 缺乏的血浆中也会影响效力， 那些在缺乏血浆中预稀释的样品具有总体较高的 价值观。 计划进行体内半衰期和恢复研究。