STANDARDIZATION OF COAGULATION FACTOR IX

一项国际合作研究是为了确定 现行WHO FIX复合物标准品，84/681（含有大量 除因子IX外，因子II、VII和K）是适当的标准 用于测定更高纯度的凝血因子的效价 IX（人类）产品。 测定的样品包括三种凝血因子IX 由巴克斯特医疗保健公司（Alpha）生产的（人）浓缩物 Therapeutics Corporation、Armour Pharmaceutical Company和One Factor IX复合物（除因子IX外，还含有因子II、VII和X） 由巴克斯特医疗保健公司生产。 所有参与者使用 因子IX的一步测定。 样品为预稀释血浆， 研究蛋白质浓度和组成对 效价测定 当样品 仅在缓冲液中预稀释，然后在1%白蛋白或FIX中预稀释 血浆不足 当前WHO FIX复合物标准品似乎是 用于更高纯度FIX效价测定的合适标准品 浓缩物。

A collaborative international study was done to determine whether the current WHO FIX Complex Standard, 84/681 (contains significant amounts of Factors II, VII, and K in addition to Factor IX) is an appropriate standard for determining the potency of the more highly purified Coagulation Factor IX (Human) products. Samples assayed included three Coagulation Factor IX (human) concentrates manufactured by Baxter Healthcare Corporation, Alpha Therapeutics Corporation, and Armour Pharmaceutical Company and one Factor IX complex (contains Factors II, VII, and X in addition to Factor IX) manufactured by Baxter Healthcare Corporation. All participants used the one-stage assay for Factor IX. Samples were prediluted plasma to investigate the effects of protein concentration and composition on the potency determination. Lower potency values were obtained when samples were prediluted in buffer only then when prediluted in 1% albumin or FIX deficient plasma. The current WHO Standard for FIX Complex appears to be a suitable standard for potency determination of the more highly purified FIX concentrates.