Back EPC successfully concludes pilot phase on monoclonal antibodies, setting the stage for future standardisation in this field

EDQM Strasbourg, France 15/07/2025
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EPC successfully concludes pilot phase on monoclonal antibodies, setting the stage for future standardisation in this field

The European Pharmacopoeia Commission (EPC) formally endorsed the conclusion of the pilot phase on monoclonal antibodies (mAbs) during its 182nd session, marking a major milestone in the development of public standards for these complex biotherapeutics.

Launched in 2014, the pilot phase aimed to explore the feasibility of establishing Ph. Eur. quality standards for therapeutic mAbs by developing individual monographs for multi-source mAbs (elaboration of monographs via Procedure 1), as well as general chapters to standardise quality attributes common to classes of mAbs. The initiative was led by the Monoclonal Antibodies Working Party (MAB WP), in close collaboration with all stakeholders, including regulatory authorities, Official Medicines Control Laboratories (OMCLs), industry and academia.

The following texts were elaborated as part of the pilot phase:

  • individual monographs:
    • Infliximab concentrated solution (2928)
    • Adalimumab concentrated solution (3147)
  • general chapters addressing key analytical techniques:
    • Cell-based assays for potency determination of TNF-alpha antagonists (2.7.26)
    • Capillary isoelectric focusing for recombinant therapeutic monoclonal antibodies (2.5.44)
    • Size-exclusion chromatography for recombinant therapeutic monoclonal antibodies (2.5.43)

Among these texts, the monograph on infliximab and the general chapters on cell-based potency assays and capillary isoelectric focusing have already been published in the European Pharmacopoeia. The draft general chapter on size-exclusion chromatography and the draft monograph on adalimumab were recently published for public consultation in Pharmeuropa 37.1 and 37.3, respectively. All the texts generated during the pilot phase reflect a flexible, science-based approach to standardisation, addressing both product-specific and class-wide requirements.

Robust and continuous stakeholder engagement played a pivotal role in the success of the pilot phase. The results of a comprehensive survey conducted in 2024 confirmed strong support for the Ph. Eur. approach, highlighting the importance of continued collaboration.

With the conclusion of the pilot phase, the MAB WP will continue its work as a regular Ph. Eur. group. It will support the development of public standards for multi-source mAbs via the Procedure 1, building on the strong foundation established through this pioneering initiative. In parallel, the P4Bio WP will continue elaborating standards for single-source mAbs via the Procedure 4. Together, these Ph. Eur. working parties will enable the Ph. Eur. to continue to address emerging priorities in the field.