Collaborative study for the establishment of the human immunoglobulin for electrophoresis Ph. Eur. BRP batch 3.

Abstract

Due to the diminished stocks of the 2(nd) batch of the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for human immunoglobulin for electrophoresis, in 2013, the European Directorate for the Quality of Medicines and HealthCare (EDQM) initiated an international collaborative study for the establishment of a replacement batch. The study was run under the aegis of the Biological Standardisation Programme (BSP). Seventeen laboratories participated in the collaborative study to verify the suitability of the candidate reference preparation according to the Ph. Eur. monographs 0338 and 0918 using the zone electrophoresis (ZE) method with either cellulose acetate and/or agarose as the testing medium. The candidate preparation was found suitable for the intended purpose and was subsequently adopted by the Ph. Eur. Commission as the human immunoglobulin for electrophoresis BRP batch 3 with an assigned range for immunoglobulin of 79.8 % to 86.4 % of the total protein content.