Lee Naery, Seo Ji Suk, Kim Jae Ok, Ban Sang Ja
National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, 187 Osongsaengmyeoung 2-ro, Osong-eup, Cheongju-si 28159, Republic of Korea.
National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, 187 Osongsaengmyeoung 2-ro, Osong-eup, Cheongju-si 28159, Republic of Korea; Health Policy and Hospital Management, Program in Public Health, Korea University College of Medicine, Anam-dong 5-ga, Seongbuk-Gu, Seoul, Republic of Korea.
Biologicals. 2017 May;47:59-63. doi: 10.1016/j.biologicals.2016.12.001. Epub 2017 Jan 11.
Since the 1st Korean national biological reference standard for factor (F)VIII concentrate, established in 2001, has shown declining potency, we conducted this study to replace this standard with a 2nd Korean national biological reference standard for blood coagulation FVIII concentrate. The candidate materials for the 2nd standard were prepared in 8000 vials with 10 IU/ml of target potency, according to the approved manufacturing process of blood coagulation Factor VIII:C Monoclonal Antibody-purified, Freeze-dried Human Blood Coagulation Factor VIII:C. Potency was evaluated by one-stage clotting and chromogenic methods and the stability was confirmed to meet the specifications during a period of 73 months. Since the potencies obtained by the two methods differed significantly (P < 0.015), the values were determined separately according to the geometric means (8.9 and 7.4 IU/vial, respectively). The geometric coefficients of interlaboratory variability were 3.4% and 7.6% by the one-stage clotting and chromogenic assays, respectively.
