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

Author(s): Mihaela Buda, PhD

Abstract: This article describes the European Pharmacopoeia (Ph. Eur.) 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. Emphasis is put on the approach used to set the […]

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