Abstract：
The European Pharmacopoeia Biological Reference Preparation (Ph. Eur. BRP) for Factor VIII Concentrate batch 5 was established through a collaborative study involving 14 laboratories organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM, Council of Europe) to be used as working standard for potency determination of human coagulation Factor VIII (FVIII) preparations. The potency of the BRP batch 5 was assigned with reference to the WHO 8th International Standard (IS) for FVIII Concentrate and the BRP batch 4. Participants were instructed to perform 3 independent Factor VIII potency assays following their own routine validated methods by the chromogenic assay as it is the assay prescribed by the European Pharmacopoeia. This publication reports the results obtained during the study. The consensus potency, 9.9 IU/ampoule (n = 14) when assessed against both standards, with inter-laboratory geometric coefficients of variation (GCV) of 3.2 % and 1.9 % against the WHO 8th IS and the BRP batch 4 respectively, was consistent with the expected value. The Ph. Eur. BRP batch 5 is a freeze-dried, plasma-derived concentrate. Based on accelerated degradation studies, the stability of the material is suitable as a reference preparation. The Ph. Eur. BRP batch 5 was adopted at the 151st session of the European Pharmacopoeia Commission in March 2015 and is available from the EDQM.
摘要：
欧洲药典生物参考制剂(Ph.欧尔.BRP）用于第5批因子VIII浓缩物是通过一项合作研究建立的，该研究涉及由欧洲药品质量与医疗保健局组织的14个实验室（EDQM，欧洲委员会）用作测定人凝血因子VIII（FVIII）制剂的效力的工作标准。BRP批次5的效力参照FVIII浓缩物的WHO第8号国际标准(IS)和BRP批次4指定。指示参与者按照他们自己的常规验证方法通过显色测定进行3次独立的因子VIII效力测定,因为它是欧洲药典规定的测定。该出版物报道了在研究期间获得的结果。共识的效力，根据两个标准进行评估时，9.9IU/安瓿（n=14），与WHO第8IS和BRP批次4相比，实验室间几何变异系数（GCV）分别为3.2％和1.9％，与预期值一致。ThePh.欧尔.BRP批次5是冻干的,血浆衍生浓缩物。基于加速降解研究，材料的稳定性适合作为参考制剂。ThePh.欧尔.BRP批次5在2015年3月的欧洲药典委员会第151届会议上通过，可从EDQM获得。
