Preparation of Factor VIII Freeze-Drying for used as a National Reference Standard

Abstract

        Factor VIII is a biopharmaceutical product for the treatment of haemophilia A patients. The injection dosage varies depending on disease severity and the specified drug label concentration. The potency testing against reference standard leads to the concentration value as international units (IU). The objective of this study was to prepare and evaluate Factor VIII freeze-dried reference standard prepared by the Institute of Biological Products for the potency testing of Factor VIII products. The evaluation of the product revealed that the variation coefficient of packing was 0.18%. The potency value was about 16.26 IU/vial and the moisture content was approximately 1.77%. The homogeneity was not signifi cantly different and it had good physical characteristics and reconstitution. Its pH was approximately 8.517. A long-term stability study in storage condition at -70°C for 150 days suggested that the potency did not decrease. An accelerated stability study suggested that appearance and pH were normal. The moisture content at 37°C was higher than those at 4°C and 25°C and the potency at 25 and 37°C declined on days 3 and 7. Thus, the lyophilized Factor VIII could be used as a reference standard for the potency testing of Factor VIII products and potency testing should be undertaken every 6 months for long-term stability evaluation.