In 2014, the European Pharmacopoeia Commission (EPC) launched a pilot phase on setting public standards for therapeutic monoclonal antibodies (mAbs) (“MAB pilot phase”). This pilot phase was intended to explore the feasibility of establishing individual monographs for multi-source mAbs, as well as the applicability of general concepts to standardisation of quality attributes common to classes of mAbs.
The EPC is currently seeking feedback from a wide range of stakeholders on the approach taken in the “MAB pilot phase” towards the concepts (including flexibility) built into mAb quality standards. The outcome of this survey will inform the final assessment of the “MAB pilot phase” and help bring this project to a close.
Completing the questionnaire will only take a few minutes of your time but will provide the EPC with invaluable information that will help determine its future strategy in the field of public standard setting for therapeutic mAbs.
Click here to participate in the survey: Strategy for Ph. Eur. quality standards for monoclonal antibodies: monographs and horizontal standards.
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