title: Establishment of hepatitis A detection antibodies set BRR batch 3 for antigen content determination by ELISA.
abstract: The current batch of the European Pharmacopoeia (Ph. Eur.) Biological Reference Reagents (BRRs) used for the in vitro potency assay of hepatitis A vaccines (HAV) by ELISA (enzymelinked immunosorbent assay) was established in 2012 for use in conjunction with Ph. Eur. general chapter 2.7.14 Assay of hepatitis A vaccine. It is composed of a coating reagent and a set of detection antibodies. As stocks of the latter are running low, the European Directorate for the Quality of Medicines & HealthCare (EDQM) organised a collaborative study to qualify replacement batches. The candidate BRR antibodies (primary monoclonal antibody and labelled secondary antibody) were prepared under appropriate conditions from starting materials similar to those used for the current batches. The new batches of antibodies were tested alongside previous batches of BRRs to ensure continuity, and the results confirmed that they were suitable for use in the potency assay of hepatitis A vaccines by ELISA using the standard method referenced in Ph. Eur. general chapter 2.7.14 at the same final concentrations as the previous batches, i.e. 1:500 for the primary monoclonal antibody and 1:400 for the secondary conjugated antibody. The outcome of the study allowed their establishment by the Ph. Eur. Commission in March 2015 as anti-hepatitis A virus primary detection antibody BRR batch 3 and conjugated secondary detection antibody BRR batch 3 respectively. They are available from the EDQM as hepatitis A vaccine ELISA detection antibodies set BRR batch 3.
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: 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, angele.costanzo@edqm.eu.
authors.forename: A
authors.initials: A
authors.lastname: Costanzo
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods / Q000592:standards*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods / Q000592:standards; D005060:Europe; D035922:Hepatitis A Antibodies / Q000032:analysis*; D035921:Hepatitis A Antigens / Q000032:analysis*; D022362:Hepatitis A Vaccines / Q000592:standards*; D006801:Humans; D010602:Pharmacopoeias as Topic / Q000592:standards*
chemical_list: D035922:Hepatitis A Antibodies; D035921:Hepatitis A Antigens; D022362:Hepatitis A Vaccines
keywords: Biological Reference Reagents; ELISA; European Pharmacopoeia; HAV; collaborative study; hepatitis A vaccine