The outcome of the recently completed Biological Standardisation Programme study for the establishment of Human immunoglobulin (molecular size) Biological Reference Preparation (BRP) replacement batches 4, 5 and 6, has been published in the online journal Pharmeuropa Bio & Scientific Notes.

The BRP replacement batches were adopted at the end of December 2023 following an international collaborative study (BSP150) with 18 participants, including European manufacturers of immunoglobulin products and Official Medicines Control Laboratories. Batch 4 will be distributed once batch 3 is exhausted, with batches 5 and 6 being used in succession as stocks are depleted.

The article describes the methods and materials used as well as the results and statistical analysis thereof.

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