Keywords: Monoclonal antibodies, pharmacopoeia, infliximab, public standards, flexibility
Author byline as per print journal: M Buda, PhD
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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