Thursday 20 September 2018

EDQM publishes a new section dedicated to biotherapeutics

As public standards for the quality of medicines in Europe, the monographs and reference standards of the European Pharmacopoeia (Ph. Eur.) play a major role in ensuring the quality of biotherapeutics, thereby contributing to overall patient safety. By providing these recognised common standards for the quality of medicines and their components, the Ph. Eur. promotes public health and ensures the safety of medicines for patients. Ph. Eur. Standards are designed to meet the needs of all stakeholders, including industry, Official Medicines Control Laboratories (OMCLs) and regulatory authorities.

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.


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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