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  • Title: Establishment of the human coagulation factor VII concentrate European Pharmacopoeia biological reference preparation batch 1.
    Author: Dodt J, Hunfeld A, Daas A, Buchheit KH.
    Journal: Pharmeuropa Bio; 2006 Nov; 2006(1):15-22. PubMed ID: 17270128.
    Abstract:
    For the potency assay of human coagulation factor VII concentrate preparations according to the European Pharmacopoeia (Ph. Eur.) a reference preparation calibrated in International Units (IU) is needed. Currently, the 1st International Standard (97/592, potency: 6.3 IU/ampoule) but no Ph. Eur. reference preparation is available. A collaborative study was run to calibrate a candidate Ph. Eur. Biological Reference Preparation (BRP) for human coagulation factor VII concentrate against the 1st International Standard; the BRP is intended to be used as working standard. A candidate BRP batch 1 was produced from a plasma-derived human factor VII concentrate preparation available on the European market. It fulfilled the requirements of a BRP with regard to precision and homogeneity of fill, residual water content and stability. In addition, the content of activated factor VII was low. Sixteen laboratories from 9 countries participated in the collaborative study. The potency of the candidate BRP was determined using the participants' chromogenic assay based on the Ph. Eur. and their in-house clotting assay, if available. The statistical model used for analysis of the results from most laboratories was the maximum likelihood of the parallel line model following a logarithmic transformation of the responses. In the chromogenic assay, a potency estimate of 8.2 IU/vial (+/-3.7%) was obtained for the candidate BRP. Results from the clotting assay were lower and less homogenous (6.7 IU/vial+/-11.6%). The results from the collaborative study showed that the candidate BRP is suitable as a reference standard for the chromogenic assay according to the Ph. Eur. It was adopted by the Ph. Eur. Commission in March 2006 as official Ph. Eur. BRP for this purpose.
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