Raut S, Costanzo A, Daas A, Buchheit K H
National Institute for Biological Standards and Control (NIBSC), Potters Bar, EN6 3QG, Herts, UK.
European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, Strasbourg, France, corresponding author's e-mail:
Pharmeur Bio Sci Notes. 2017;2017:1-11.
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 8 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 8 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 151 session of the European Pharmacopoeia Commission in March 2015 and is available from the EDQM.
欧洲药典第5批凝血因子VIII浓缩物生物参考制剂（欧洲药典生物参考制剂）是通过欧洲药品质量管理局（欧洲委员会下属机构）组织的一项有14个实验室参与的协作研究建立的，用作人凝血因子VIII（FVIII）制剂效价测定的工作标准品。第5批生物参考制剂的效价是参照世界卫生组织第8国际标准品（IS）和第4批生物参考制剂确定的。要求参与者按照各自经验证的常规方法，采用欧洲药典规定的发色底物法进行3次独立的凝血因子VIII效价测定。本出版物报告了该研究期间获得的结果。与两种标准品相比，第5批生物参考制剂的一致性效价为9.9 IU/安瓿（n = 14），相对于世界卫生组织第8国际标准品和第4批生物参考制剂的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。欧洲药典第5批生物参考制剂为冻干的血浆源性浓缩物。基于加速降解研究，该物质的稳定性适合作为参考制剂。欧洲药典第5批生物参考制剂于2015年3月在欧洲药典委员会第151届会议上被采用，可从欧洲药品质量管理局获得。
