title: European Pharmacopoeia biological reference preparation for poliomyelitis vaccine (inactivated): collaborative study for the establishment of batch No. 3.
abstract: 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 anin vitroD 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 3rdInternational 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.
authors.affiliation: National Institute for Biological Standards and Control (NIBSC), Blanche Lane, South Mimms, Potters Bar, Herts, EN6 3QG, United Kingdom.
authors.forename: J
authors.initials: J
authors.lastname: Martin
authors.affiliation: European Directorate for the Quality of Medicines & HealthCare (EDQM), Department of Biological Standardisation, OMCL Network & HealthCare (DBO), Council of Europe, Strasbourg, France.
authors.forename: A
authors.initials: A
authors.lastname: Daas
authors.affiliation: 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 e-mail: catherine.milne@edqm.eu.
authors.forename: C
authors.initials: C
authors.lastname: Milne
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods / Q000592:standards*; D005060:Europe; D006801:Humans; D007391:International Cooperation; D010602:Pharmacopoeias as Topic / Q000592:standards*; D011051:Poliomyelitis / Q000517:prevention & control; D011054:Poliovirus Vaccine, Inactivated / Q000592:standards* / Q000627:therapeutic use; D012015:Reference Standards
chemical_list: D011054:Poliovirus Vaccine, Inactivated
keywords: D antigen; European Pharmacopoeia; biological reference preparation; collaborative study; in vitro assay; poliomyelitis vaccine (inactivated)