title: Establishment of hepatitis A vaccine (inactivated, non-adsorbed) BRP batches 2 and 3.
abstract: The current hepatitis A vaccine (HAV), inactivated, non-adsorbed, European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) is used for the in vitro potency assay of HAV as prescribed by the Ph. Eur. general chapter 2.7.14 Assay of hepatitis A vaccine. This reference preparation was calibrated in 2008 through an international collaborative study and was assigned a potency of 12 IU/mL. During use of this BRP it appeared to be inapplicable in certain cases due to a low nominal antigen content. Consequently, the European Directorate for the Quality of Medicines and HealthCare (EDQM) established replacement batches for this BRP, calibrated against the 1(st) WHO International Standard (IS) for HAV (inactivated), using the standard in vitro ELISA (enzyme-linked immunosorbent assay) method validated previously. The results of the study showed that the candidate BRPs were suitable for the intended purpose, and following completion of the study, they were adopted in November 2014 by the Ph. Eur. Commission as HAV (inactivated, non-adsorbed) BRP batches 2 and 3, with an assigned potency of 1350 IU/mL, for in vitro antigen content determination by ELISA. As the amount of material in each vial largely exceeds the amount required for the performance of a single assay, the BRPs are to be aliquoted by users as single-use aliquots and refrozen below -50 °C prior to their use as reference preparations.
authors.affiliation: Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), Pôle libération de lots et surveillance du marché des produits biologiques, Direction des Contrôles, Lyon, France.
authors.forename: S
authors.initials: S
authors.lastname: Morgeaux
authors.affiliation: Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), Pôle contrôles biologiques des médicaments immunologiques, sécurité biologique, Direction des Contrôles, Lyon, France.
authors.forename: I
authors.initials: I
authors.lastname: Manniam
authors.affiliation: Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), Pôle contrôles biologiques des médicaments immunologiques, sécurité biologique, Direction des Contrôles, Lyon, France.
authors.forename: P
authors.initials: P
authors.lastname: Variot
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: K H
authors.initials: KH
authors.lastname: Buchheit
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.
authors.forename: M
authors.initials: M
authors.lastname: Wierer
authors.affiliation: European Directorate for the Quality of Medicines & HealthCare (EDQM), Department of Biological Standardisation, OMCL Network & HealthCare (DBO), Council of Europe, Strasbourg, France, angele.costanzo@edqm.eu.
authors.forename: A
authors.initials: A
authors.lastname: Costanzo
mesh_terms: D002138:Calibration; D002626:Chemistry, Pharmaceutical / Q000379:methods / Q000592:standards*; D005060:Europe; D022362:Hepatitis A Vaccines / Q000032:analysis* / Q000592:standards*; D012015:Reference Standards; D015164:Vaccines, Inactivated / Q000032:analysis / Q000592:standards; D014944:World Health Organization
chemical_list: D022362:Hepatitis A Vaccines; D015164:Vaccines, Inactivated
keywords: Biological Reference Preparation; ELISA; European Pharmacopoeia; HAV; antigen content assay; biological standardisation; collaborative study; hepatitis A vaccine