National Institute for Biological Standards and Control (NIBSC), Blanche Lane, South Mimms, Potters Bar, EN6 3QG, UK.
European Directorate for the Quality of Medicines & HealthCare, Department of Biological Standardisation, OMCL Network & HealthCare (DBO), Council of Europe, Strasbourg, France.
Pharmeur Bio Sci Notes. 2021;2021:88-100.
The European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for human coagulation Factor VIII (FVIII) Concentrate is used as working standard for potency determination of human coagulation FVIII preparations by chromogenic assay. BRP batch 5 was established in 2015 and its stocks were running low. Therefore, the European Directorate for the Quality of Medicines & HealthCare (EDQM) initiated a project (BSP156) for the calibration of a replacement batch. The potency of BRP batch 6 was assigned during an international collaborative study involving 16 laboratories worldwide, with reference to the WHO 8th International Standard (IS) and BRP batch 5. Participants were instructed to perform 3 independent FVIII potency assays following their own routine validated methods for the chromogenic assay, which is the assay prescribed by the Ph. Eur. As an outcome of the study, Ph. Eur. human coagulation FVIII Concentrate BRP batch 6 was assigned a consensus potency of 9.9 IU/ampoule for the chromogenic assay. The Ph. Eur. BRP batch 6 is a freeze-dried, plasma-derived concentrate. Based on accelerated degradation studies, the stability of the material is suitable for a reference preparation. The Ph. Eur. BRP batch 6 was adopted at the 167th session of the Ph. Eur. Commission in June 2020 and is available from the EDQM under product code H0920000.
《欧洲药典》（Ph. Eur.）人凝血因子 VIII（FVIII）浓缩物生物参考制剂（BRP）用作比色法测定人凝血因子 VIII 制剂效价的工作标准。BRP 批 5 于 2015 年建立，库存已接近枯竭。因此，欧洲药品质量管理局（EDQM）启动了一个项目（BSP156），用于校准替代批。在一项涉及全球 16 个实验室的国际协作研究中，根据世界卫生组织第 8 号国际标准（IS）和 BRP 批 5，确定了 BRP 批 6 的效价。研究参与者被要求按照自己的常规验证方法进行 3 次独立的 FVIII 效价测定，该方法是 Ph. Eur. 规定的比色法。作为研究的结果，Ph. Eur. 人凝血因子 VIII 浓缩物 BRP 批 6 被分配了共识效价为 9.9IU/安瓿，用于比色法。Ph. Eur. BRP 批 6 是一种冷冻干燥的血浆衍生浓缩物。根据加速降解研究，该材料的稳定性适合作为参考制剂。Ph. Eur. BRP 批 6 于 2020 年 6 月在第 167 届 Ph. Eur. 委员会会议上获得通过，并可从 EDQM 获得产品代码 H0920000。
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