Akkermans A M, Waeterloos G, Kemiha K, Daas A, Milne C
National Institute for Public Health and the Environment, Bilthoven, The Netherlands.
Pharmeur Bio Sci Notes. 2009 Oct;2009(1):41-54.
The European Pharmacopoeia (Ph. Eur.) monograph for varicella vaccine (live) (0648) requires a vial of an appropriate reference material to be titred in triplicate to validate each assay and the virus concentration of the reference preparation is monitored using a control chart to determine the assay consistency. An international collaborative study involving 9 participants from 7 countries and including both OMCLs and manufacturers was carried out to establish a common reference material for this purpose and establish a Ph. Eur. Biological Reference Preparation. Two candidate reference preparations (X and Y), obtained from 2 different EU manufacturers, were assayed by the participants using their in-house PFU assay methods. Both candidates were found to be suitable for this purpose. Based on logistical considerations, candidate X (4.37 log(10)0 PFU/vial) has been established as BRP batch 1 of varicella vaccine (live) and was adopted at the June 2009 session of the European Pharmacopoeia Commission for immediate use. Candidate Y (3.82 log(10) PFU/vial) will be established as BRP batch 2 upon depletion of BRP batch 1 provided that the stability data supports this.
欧洲药典（Ph. Eur.）中水痘疫苗（活疫苗）（0648）的专论要求对一瓶适当的参考物质进行三次滴定，以验证每次测定，并且使用控制图监测参考制剂的病毒浓度，以确定测定的一致性。为此，开展了一项国际协作研究，有来自7个国家的9名参与者，包括官方药品控制实验室（OMCLs）和生产商，目的是建立一种通用参考物质，并建立一种欧洲药典生物参考制剂。参与者使用其内部的蚀斑形成单位（PFU）测定方法，对从欧盟2家不同生产商获得的两种候选参考制剂（X和Y）进行了测定。发现这两种候选制剂均适用于此目的。基于后勤方面的考虑，候选制剂X（4.37 log(10)0 PFU/瓶）已被确立为水痘疫苗（活疫苗）的生物参考制剂第1批，并在欧洲药典委员会2009年6月会议上被采用，可立即使用。如果稳定性数据支持，候选制剂Y（3.82 log(10) PFU/瓶）将在生物参考制剂第1批用完后被确立为生物参考制剂第2批。
