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The European Directorate for the Quality of Medicines & Healthcare highlighted the organization’s achievements in 2017, including the first mAb monograph.
The European Directorate for the Quality of Medicines & Healthcare (EDQM) announced the publication of its
on July 2, 2018, which highlights the technical and scientific advances the organization made last year. The report covers monographs and reference standards adopted in 2017, the Biological Standardsation Programme, and harmonization initiatives.
Mentioned in the report is the European Pharmacopoeia’s adoption of the first monograph on a monoclonal antibody (mAb), Infliximab concentrated solution (2928), which according to EDQM, advances the quality control of biotherapeutics. Other biologic advances included 29 projects conducted as part of the Biological Standardisation Programme, a joint European Union/Council of Europe initiative to develop and validate new quality control methods for biologics. Additionally, 14 projects were developed to establish replacement batches for existing reference standards for biologics, and nine projects focused on the development of compendial methods.
“We are most pleased with the progress achieved in the fields of biotherapeutic products and animal protection, in addition to the 35 new and more than 220 revised texts adopted to incorporate scientific and technological progress and regulatory changes,” stated Susanne Keitel, director of EDQM, in the report’s forward.