Ph. Eur. Commission adopts first “horizontal standard” for monoclonal antibodie
“At its 172nd session in March 2022, the European Pharmacopoeia (Ph. Eur.) Commission adopted a new general chapter, Cell-based assay for potency determination of TNF-alpha antagonists (2.7.26), the first of three planned new horizontal standards for monoclonal antibodies (mAbs).
The adoption of the new chapter marks an important milestone in the Ph. Eur. Commission’s efforts to develop – in response to stakeholder demand – a set of widely applicable recommendations for analytical testing strategies that cover the needs of different classes and sub-classes of mAbs. The resulting “horizontal standards” or “performance-based standards” comprise well-defined analytical procedures and tools to control performance and facilitate analytical assessment of key quality attributes of mAbs”.
More info: https://www.edqm.eu/en/-/ph.-eur.-commission-adopts-first-horizontal-standard-for-monoclonal-antibodies
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egennet (20 juillet 2022). Ph. Eur. Commission adopts first “horizontal standard” for monoclonal antibodie. ELSIBI. Consulté le 7 octobre 2026 à l’adresse https://doi.org/10.58079/o60d
