Standardisation of Monoclonal Antibodies (mAbs) by the EPC

In July 2025, the European Pharmacopoeia Commission (EPC) officially completed the pilot phase for the development of public standards for monoclonal antibodies (mAbs). This project, which was launched in 2014, represents a milestone in biopharmaceutical quality assurance. The aim was to develop both product-specific monographs and general chapters in order to standardise common quality attributes of mAbs.

Two approaches were pursued:      

• Procedure 1: Creation of monographs for multiple sources (multi-source mAbs)
  
• Procedure 4: Development of standards for products with a single source (single-source mAbs)

The work was led by the Monoclonal Antibodies Working Party (MAB WP) in collaboration with authorities, OMCLs, industry and academic institutions.

Results of the pilot phase

The following texts were developed as part of the project:

Individual monographs:

• Infliximab, concentrated solution (2928)
• Adalimumab, concentrated solution (3147)

General chapters on analytical techniques:

• Cell-based assays for potency determation of TNF-alpha antagonists (Chapter 2.7.26)
• Capillary isoelectric focusing for recombinant therapeutic monoclonal antibodies (Chapter 2.5.44)
• Size-exclusion chromatography for recombinant therapeutic monoclonal antibodies (Chapter 2.5.43)

Some of these texts - including the monograph on infliximab and two general chapters - have already been published in the Ph. Eur. Others, such as the adalimumab monograph, are still undergoing public consultation (Pharmeuropa 37.1 and 37.3).  All the texts developed reflect a flexible, science-based approach that takes into account both product-specific and cross-class requirements.

With the completion of the pilot phase, the MAB WP will become a permanent working group of the Ph. Eur. This group will continue to drive forward the standardisation of multi-source mAbs via Procedure 1. In parallel, the P4Bio WP will further develop the standards for single-source mAbs. Together, both groups will ensure that new scientific and regulatory requirements in the field of mAbs can be addressed in the future. 

The successful completion of the pilot phase for the standardisation of monoclonal antibodies underscores the Ph. Eur.'s commitment to developing robust, harmonised quality standards in the field of complex biologics. This initiative paves the way for future drug monographs and contributes significantly to global harmonisation and regulatory certainty. You can read the full announcement on the official EDQM website.