Martin J, Daas A, Milne C
National Institute for Biological Standards and Control (NIBSC), Blanche Lane, South Mimms, Potters Bar, Herts, EN6 3QG, United Kingdom.
European Directorate for the Quality of Medicines & HealthCare (EDQM), Department of Biological Standardisation, OMCL Network & HealthCare (DBO), Council of Europe, Strasbourg, France.
Pharmeur Bio Sci Notes. 2016;2016:135-150.
Inactivated poliomyelitis vaccines are an important part of the World Health Organization (WHO) control strategy to eradicate poliomyelitis. Requirements for the quality control of poliomyelitis vaccines (inactivated) include the use of an D antigen quantification assay for potency determination on the final lot as outlined in the European Pharmacopoeia (Ph. Eur.) monograph 0214. Performance of this assay requires a reference preparation calibrated in International Units (IU). A Ph. Eur. biological reference preparation (BRP) for poliomyelitis vaccine (inactivated) calibrated in IU has been established for this purpose. Due to the dwindling stocks of batch 2 of the BRP a collaborative study was run as part of the European Directorate for the Quality of Medicines & HealthCare (EDQM) Biological Standardisation Programme to establish BRP batch 3 (BRP3). Twelve laboratories including Official Medicines Control Laboratories (OMCLs) and manufacturers participated. The candidate BRP3 (cBRP3) was from the same source and had the same characteristics as BRP batch 2 (BRP2). During the study the candidate was calibrated against the 3 International Standard for inactivated poliomyelitis vaccine using in-house D antigen ELISA assays in line with the Ph. Eur. monograph 0214. The candidate was also compared to BRP2 to evaluate the continuity. Based on the results of the study, values of 320 DU/mL, 78 DU/mL and 288 DU/mL (D antigen units/mL) (IU) for poliovirus type 1, 2 and 3 respectively were assigned to the candidate. In June 2016, the Ph. Eur. Commission adopted the material as Ph. Eur. BRP for poliomyelitis vaccine (inactivated) batch 3.
灭活脊髓灰质炎疫苗是世界卫生组织（WHO）根除脊髓灰质炎控制策略的重要组成部分。脊髓灰质炎疫苗（灭活）的质量控制要求包括按照欧洲药典（Ph. Eur.）专论0214中所述，使用D抗原定量测定法对最终批次进行效力测定。该测定法的实施需要使用以国际单位（IU）校准的参考制剂。为此已建立了以IU校准的欧洲药典脊髓灰质炎疫苗（灭活）生物参考制剂（BRP）。由于BRP第2批次的库存不断减少，作为欧洲药品质量管理局（EDQM）生物标准化计划的一部分开展了一项合作研究，以建立BRP第3批次（BRP3）。包括官方药品控制实验室（OMCLs）和生产商在内的12个实验室参与了研究。候选BRP3（cBRP3）与BRP第2批次（BRP2）来源相同且特性相同。在研究期间，使用符合欧洲药典专论0214的内部D抗原ELISA测定法，将候选制剂与灭活脊髓灰质炎疫苗国际标准品进行校准。还将候选制剂与BRP2进行比较以评估连续性。根据研究结果，分别为脊髓灰质炎病毒1型、2型和3型的候选制剂指定了320 DU/mL、78 DU/mL和288 DU/mL（D抗原单位/mL）（IU）的值。2016年6月，欧洲药典委员会采用该材料作为欧洲药典脊髓灰质炎疫苗（灭活）第3批次的BRP。
