Thursday, 21 June 2018

First Ph. Eur. monograph on a monoclonal antibody


The European Pharmacopoeia Commission has achieved an important milestone in the field of biotherapeutic products with the adoption of the monograph for Infliximab concentrated solution (2928).

The Ph. Eur. Commission embarked upon the setting of public standards for therapeutic monoclonal antibodies (mAbs) in 2014 with a pilot phase and following extensive consultation with its stakeholders.

See: https://www.edqm.eu/en/node/16070

Posted by Dr. Tim Sandle

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