A new article on the outcome of the study for the establishment of replacement batches of reference standards to control the level of anti-D antibodies in human immunoglobulin products for intravenous administration has been published in the online journal Pharmeuropa Bio & Scientific Notes.

The publication provides a detailed description of the method, materials and results of an international collaborative study (BSP131) during which the European Pharmacopoeia Immunoglobulin (anti-D antibodies test) Biological Reference Preparation (BRP) batch 2 and Immunoglobulin (anti-D antibodies test negative control) BRP batch 2 were established. The study was conducted jointly by the United States Food & Drug Administration, the National Institute for Biological Standards and Control (now the Medicines & Healthcare products Regulatory Agency, a World Health Organization collaborating centre) and the EDQM Biological Standardisation Programme (BSP), thus ensuring harmonised reference standards across the three institutions.

Pharmeuropa Bio & Scientific Notes is published by the EDQM and referenced on MedLine.