title: Collaborative study for the establishment of the 2(nd) International Standard for Bleomycin Complex A2/B2.
abstract: Organization (WHO) International Standard (IS) for bleomycin complex A2/B2. Eight laboratories from different countries participated. Potencies of the candidate material were estimated by microbiological assays with sensitive micro-organisms. To ensure continuity between consecutive batches, the 1(st) IS for bleomycin complex A2/B2 was used as a reference. Based on the results of the study, the 2(nd) IS for bleomycin complex A2/B2 was adopted at the meeting of the WHO Expert Committee for Biological Standardization (ECBS) in 2014 with an assigned potency of 12 500 International Units (IU) per vial. The 2(nd) IS for bleomycin complex A2/B2 is available from the European Directorate for the Quality of Medicines & HealthCare (EDQM).
authors.affiliation: European Directorate for the Quality of Medicines & HealthCare (EDQM), Department of Biological Standardisation, OMCL Network & HealthCare (DBO), Council of Europe, Strasbourg, France, sylvie.jorajuria@edqm.eu.
authors.forename: S
authors.initials: S
authors.lastname: Jorajuria
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: C
authors.initials: C
authors.lastname: Raphalen
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: V
authors.initials: V
authors.lastname: Dujardin
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
mesh_terms: D000900:Anti-Bacterial Agents / Q000592:standards*; D001761:Bleomycin / Q000592:standards*; D006801:Humans; D007391:International Cooperation; D012015:Reference Standards; D014944:World Health Organization
chemical_list: D000900:Anti-Bacterial Agents; D001761:Bleomycin
keywords: Bleomycin; WHO International Standard; antibiotic; collaborative study; microbiological assay