WANG Min-li1,ZHAO Hui1,WANG Wei1,ZHU Shuang-li2,XU Wen-bo2,QIN Ting-ting3,LIU Rui-xi3,DING Yong4,ZHANG Xiao4,GUAN Li-dong1,SUN Si-cai5, SHI Xin-chang1, HOU Ji-feng1*
1.National Institutes for Food and Drug Control, Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, Beijing 100050, China; 2.Chinese Center for Disease Control and Prevention,National Institute for Viral Disease Control and Prevention,Beijing 100050, China; 3.Chengdu Rongsheng Pharmaceuticals,Co.,Ltd, Chengdu 610000,China; 4.Tonrol Bio-Pharmaceutical Co.,Ltd, Hefei 230000, China; 5. Jiangxi Boya Biological Pharmaceutical Co., Ltd,Fuzhou 344000, China
Abstract��
OBJECTIVE To prepare the first batch of national standard for enterovirus 71 immunoglobulin for the efficacy test ofEV71 human immunology products.METHODS The domestic intravenous immunoglobulin products with batch release certification and high efficacy EV71 immunoglobulin products were mixed, filled, and lyophilized under aseptic conditions to get the first batch of national standard for enterovirus 71 immunoglobulin. The standards were distributed to five laboratories for cooperative calibration according to the unified SOP for microneutralization test. Neutralizing titer which corresponded to the reciprocal of the highest serum dilution that neutralized enterovirus 71 was defined as the efficacy (reported as unit) of the national standard. Sterility test, moisture determination,precision for filling test, and stability of potency were verified.RESULTS A total of 63 calibration tests were carried out by the five collaboration laboratories,and the results were statistically analyzed after logistic convertion.The inter-laboratories variations varied from 1.5%-4.1% and the intra-laboratories variation was 3.1%. The geometric mean of the prepared national EV71 immunoglobulin standard was 327 U and defined as 330 U for convenience of use. The potency of the prepared standard was stable after 22m and the contents of monomer plus dimer determined by HPLC-SEC were more than 98.0% during storage at a wide range of temperatures. The prepared national EV71 immunoglobulin standard was qualified in the sterility test, and the moisture content and precision for filling were 0.6% and 0.56%, respectively.CONCLUSION The prepared national EV71 immunoglobulin standard met all the relevant requirements and may be served as the first generation of national standard for the potency test of EV71 immunoglobulin products.
WANG Min-Li-,
ZHAO Hui-,
WANG Wei- etc
.Preparation of National Standard for Enterovirus 71 Immunoglobulin[J] Chinese Pharmaceutical Journal, 2015,V50(5): 431-434
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