title: Calibration of the Ph. Eur. human coagulation Factor VIII concentrate BRP batch 5.
abstract: The European Pharmacopoeia Biological Reference Preparation (Ph. Eur. BRP) for Factor VIII Concentrate batch 5 was established through a collaborative study involving 14 laboratories organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM, Council of Europe) to be used as working standard for potency determination of human coagulation Factor VIII (FVIII) preparations. The potency of the BRP batch 5 was assigned with reference to the WHO 8thInternational Standard (IS) for FVIII Concentrate and the BRP batch 4. Participants were instructed to perform 3 independent Factor VIII potency assays following their own routine validated methods by the chromogenic assay as it is the assay prescribed by the European Pharmacopoeia. This publication reports the results obtained during the study. The consensus potency, 9.9 IU/ampoule (n = 14) when assessed against both standards, with inter-laboratory geometric coefficients of variation (GCV) of 3.2 % and 1.9 % against the WHO 8thIS and the BRP batch 4 respectively, was consistent with the expected value. The Ph. Eur. BRP batch 5 is a freeze-dried, plasma-derived concentrate. Based on accelerated degradation studies, the stability of the material is suitable as a reference preparation. The Ph. Eur. BRP batch 5 was adopted at the 151stsession of the European Pharmacopoeia Commission in March 2015 and is available from the EDQM.
authors.affiliation: National Institute for Biological Standards and Control (NIBSC), Potters Bar, EN6 3QG, Herts, UK.
authors.forename: S
authors.initials: S
authors.lastname: Raut
authors.affiliation: European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, Strasbourg, France, corresponding author's e-mail: angele.costanzo@edqm.eu.
authors.forename: A
authors.initials: A
authors.lastname: Costanzo
authors.affiliation: European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, Strasbourg, France.
authors.forename: A
authors.initials: A
authors.lastname: Daas
authors.affiliation: European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, Strasbourg, France.
authors.forename: K H
authors.initials: KH
authors.lastname: Buchheit
mesh_terms: D002138:Calibration / Q000592:standards; D002626:Chemistry, Pharmaceutical / Q000379:methods / Q000592:standards*; D005060:Europe; D005169:Factor VIII / Q000032:analysis* / Q000592:standards*; D006801:Humans; D010602:Pharmacopoeias as Topic / Q000592:standards*
chemical_list: C078147:F8 protein, human; D005169:Factor VIII
keywords: BSP; Biological Reference Preparation; European Pharmacopoeia; WHO 8th International Standard; biological standardisation; chromogenic assay; collaborative study; human coagulation Factor VIII; reference standard