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

Miles生产的重组FVIII和 由巴克斯特在一阶段和两阶段试验以及显色试验中进行 表明批间和批内均存在异常程度的 可变性 相同测定的单个运行之间的差异可以 偏离标示效价达100%。 两种产品的预稀释 在白蛋白或因子VIII缺乏的血浆中也影响效力， 对于那些在缺乏血浆中预稀释的样品， 价值观 计划进行体内半衰期和恢复研究。

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.