Development of Ph. Eur. standards for therapeutic monoclonal antibodies: infliximab case study

Category: Original Research
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Keywords: Monoclonal antibodies, pharmacopoeia, infliximab, public standards, flexibility

Author byline as per print journal: 
M Buda, PhD

This article describes the European Pharmacopoeia exploratory study on infliximab as a test case for developing public standards for monoclonal antibodies. The design and outcome of the feasibility study, importance of interaction with stakeholders and the challenges and lessons learned are discussed. It examines current thinking based on the outcome of the infliximab case study and how the knowledge gained can be used to evolve the strategy laid down in the roadmap envisaged for the development of further public standards for monoclonal antibodies.


In response to stakeholder demand, in 2014 the European Pharmacopoeia (Ph. Eur.) Commission embarked upon a project to set new public standards for therapeutic monoclonal antibodies (mAbs). The aim of the project was twofold: develop general methodologies applicable to a wide range of mAbs and, at the same time, elaborate individual monographs for mAbs using a multisource approach that takes into account the specifications of more than one marketed product (“multisource mAb”). A ‘bottom-up’ approach was designed to help build and continually develop the strategy, progressing from specific (i.e. product-specific monographs) to general (i.e. general methodologies, product-class/sub-class monographs) quality attribute requirements (Figure 1). In pursuit of these goals, a case study was carried out using infliximab as a concrete example to assess the robustness of the approach and to investigate the feasibility of establishing a product-specific monograph for a complex, multisource mAb. The knowledge gained might then be used to expand the project to develop other Ph. Eur. texts applicable to mAbs.

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This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. 

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