Jpn. J. Infect. Dis., 59 (1), 20-24, 2006
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Original Article
Standardization of Regional Reference for Mamushi (Gloydius blomhoffii) Antivenom in Japan, Korea, and China
Tadashi Fukuda*, Masaaki Iwaki, Seung Hwa Hong1, Ho Jung Oh1, Zhu Wei2, Kazunori Morokuma3, Kunio Ohkuma3, Lei Dianliang4, Yoshichika Arakawa and Motohide Takahashi
Department of Bacterial Pathogenesis and Infection Control, National Institute of Infectious Diseases, Tokyo 208-0011; 3First, Production Department, Chemo-Sero-Therapeutic Research Institute, Kumamoto 860-8568, Japan; 1Korea Food and Drug Administration, Soul 122-704, Korea; 2Shanghai Institute of Biological Products, Shanghai 200052; and 4Department of Serum, National Institute for the Control of Pharmaceutical and Biological Products, Beijing 10050, Peoplefs Republic of China
(Received June 27, 2005. Accepted November 11, 2005)
*Corresponding author: Mailing address: Department of Bacterial Pathogenesis and Infection Control, National Institute of Infectious Diseases, 4-7-1 Gakuen, Musashimurayama, Tokyo 208-0011, Japan. Tel: +81-42-561-0771 ext 545, Fax: +81-42-561-7173, E-mail: yfukuda@nih.go.jp
SUMMARY: The mamushi (Gloydius blomhoffii) snakes that inhabit Japan, Korea, and China produce venoms with similar serological characters to each other. Individual domestic standard mamushi antivenoms have been used for national quality control (potency testing) of mamushi antivenom products in these countries, because of the lack of an international standard material authorized by the World Health Organization. This precludes comparison of the results of product potency testing among countries. We established a regional reference antivenom for these three Asian countries. This collaborative study indicated that the regional reference mamushi antivenom has an anti-lethal titer of 33,000 U/vial and anti-hemorrhagic titer of 36,000 U/vial. This reference can be used routinely for quality control, including national control of mamushi antivenom products.