To comply with European Pharmacopoeia (Ph. Eur.) monograph Human albumin solution (0255), albumin solutions have to be tested for molecular-size distribution by size-exclusion chromatography (SEC). However, differences in interpretation of the test results continue to be observed among albumin manufacturers in Europe. A collaborative study was run by the European Directorate for the Quality of Medicines & HealthCare (EDQM), under the aegis of the Biological Standardisation Programme (BSP), to support the revision of Ph. Eur. monograph 0255 and to establish a Biological Reference Preparation (BRP) for use in the molecular-size distribution test. In 2019, Ph. Eur. Expert Group 6B proposed to include an analytical improvement of the SEC procedure in the monograph, which was then submitted for public enquiry. This publication describes the evaluation of three candidate BRPs to serve as a tool for both the system suitability test (SST) and albumin monomer and dimer peak identification according to the proposed revised methodology. Three Official Medicines Control Laboratories (OMCLs) involved in the official batch release of human albumin solution took part in the study. Based on the study results, the candidate BRPs were found suitable for purpose and were adopted by the Ph. Eur. Commission as Ph. Eur. Human albumin (molecular size) BRP batches 1, 2 and 3 concomitantly with the revised monograph Human albumin solution (0255) in November 2020.
Keywords: Biological Reference Preparation; Biological Standardisation Programme; Council of Europe; European Directorate for the Quality of Medicines & HealthCare; European Pharmacopoeia; collaborative study; human albumin; molecular-size distribution.
© Council of Europe, 2021.