Baylis S A, Terao E, Blümel J, Hanschmann K-M O
Paul-Ehrlich-Institut (PEI), Langen, Germany.
European Directorate for the Quality of Medicines & HealthCare (EDQM), Department of Biological Standardisation, OMCL Network & HealthCare (DBO), Council of Europe, Strasbourg, France, corresponding author's email:
Pharmeur Bio Sci Notes. 2017;2017:12-28.
A new European Pharmacopoeia (Ph. Eur.) biological reference preparation (BRP) had to be established further to the decision to include nucleic acid testing (NAT) for the detection of hepatitis E virus (HEV) RNA in the monograph Human plasma (pooled and treated for virus inactivation) (1646). To this purpose, an international collaborative study was launched in the framework of the Biological Standardisation Programme (BSP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the Commission of the European Union (EU). The study was run in conjunction with the establishment of the 1 World Health Organization (WHO) international reference panel (IRP) for hepatitis E virus RNA genotypes (8578/13). Twenty-three laboratories used in-house developed and commercially available assays to calibrate a lyophilised candidate BRP prepared from a HEV 3f strain positive human plasma against the 1 WHO International Standard (IS) for HEV RNA (6329/10). Results from quantitative and qualitative assays were in good agreement and were combined to calculate an assigned potency. Real-time stability studies indicated that the candidate BRP is very stable at lower temperatures and is thus suitable for long-term use. Based on these results, in February 2016, the Ph. Eur. Commission adopted the candidate material as the hepatitis E virus RNA for NAT testing BRP batch 1, with an assigned unitage of 2.1 × 10 IU/vial (4.32 log IU/vial).
鉴于在《人血浆（混合并经病毒灭活处理）》（1646）专论中决定纳入用于检测戊型肝炎病毒（HEV）RNA的核酸检测（NAT），因此必须建立一种新的欧洲药典（Ph. Eur.）生物参考制剂（BRP）。为此，在欧洲药品与医疗保健质量管理局（EDQM）和欧盟委员会（EU）的生物标准化计划（BSP）框架内开展了一项国际合作研究。该研究与世界卫生组织（WHO）戊型肝炎病毒RNA基因型国际参考品（IRP）（8578/13）的建立同时进行。23个实验室使用内部开发的和市售的检测方法，以针对WHO戊型肝炎病毒RNA国际标准品（IS）（6329/10）校准从一株HEV 3f型阳性人血浆制备的冻干候选BRP。定量和定性检测结果高度一致，并结合起来计算指定效价。实时稳定性研究表明，候选BRP在较低温度下非常稳定，因此适合长期使用。基于这些结果，2016年2月，Ph. Eur.委员会采用该候选材料作为用于NAT检测的戊型肝炎病毒RNA BRP第1批，指定单位效价为2.1×10 IU/瓶（4.32 log IU/瓶）。
