Calibration of Human Coagulation Factor VII Concentrate Ph. Eur. BRP Batch 2

Last updated on 22-8-2019 by Anonymous (non vérifié)

Sci. report, recommendat°, guidance doc., directive, monograph



The potency assay of human coagulation factor VII concentrate preparations as described in the EuropeanPharmacopoeia (Ph. Eur.) requires a reference preparation calibrated in International Units (IU). The current Ph. Eur.Biological Reference Preparation (BRP) batch 1 was established in 2005 during an international collaborative study. Ithas an assigned potency of 8.2 IU/vial for the chromogenic assay method. Stocks of this BRP are dwindling and areplacement batch needs to be established.A candidate material was produced by a manufacturer from a plasma-derived concentrate preparation, with t…

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