Back Online publication on study for establishment of new Golimumab BRP

EDQM Strasbourg, France 10/02/2025
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Online publication on study for establishment of new Golimumab BRP

The outcome of a successful Biological Standardisation Programme study (BSP164) for the establishment of a new European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for golimumab, a fully human therapeutic TNF targeting monoclonal antibody, has been published in the online journal Pharmeuropa Bio & Scientific Notes.

The study was run as a joint study to establish both the World Health Organization (WHO) 1st International Standard (IS) and Ph. Eur. BRP batch 1 for the potency assay of golimumab. The BRP was adopted by the European Pharmacopoeia Commission for use in the monograph Golimumab concentrated solution (3103).

The BRP is available from the EDQM under catalogue number Y0002502.

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