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EDQM publishes a new section dedicated to biotherapeutics on its website

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European Pharmacopoeia
Biologicals
News
29 June 2018
Strasbourg, France

The new biotherapeutics section on the EDQM website summarises Ph. Eur. Commission activities and achievements in this field. In addition to clarification of the role of Ph. Eur. monographs in the biosimilars regulatory pathway, it describes the recently concluded P4-BIO pilot phase and the ongoing pilot phase on monoclonal antibodies (“MAB pilot phase”), explaining the strategy followed by the Ph. Eur. when setting requirements for the quality of this important class of biotherapeutics.

It also describes various levels of flexibility integrated into Ph. Eur. texts, including those introduced recently to address the structural complexity, heterogeneity and compound diversity derived from different manufacturing processes of complex biotherapeutics.

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