Regulatory science accelerates the development of biotechnology drugs and vaccines by NIFDC

被引：1
作者：
Liang, Zhenglun [1 ]
Mao, Qunying [1 ]
Wang, Yiping [1 ]
Li, Changgui [1 ]
Gao, Kai [1 ]
Wang, Junzhi [1 ]
机构：
[1] Natl Inst Food & Drug Control, Beijing 100050, Peoples R China
来源：
EMERGING MICROBES & INFECTIONS | 2014年 / 3卷
关键词：
biotechnology drug; quality control; vaccine; ENTEROVIRUS; 71; VACCINE; PANDEMIC INFLUENZA VACCINE; NEUTRALIZING ANTIBODY; UNIVERSAL ANTIBODIES; DOUBLE-BLIND; SAFETY; IMMUNOGENICITY; EFFICACY; STANDARD; SUBTYPES;
D O I：
10.1038/emi.2014.66
中图分类号：
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号：
100102 ;
摘要：
The Chinese National Institutes for Food and Drug Control (NIFDC) is the national laboratory responsible for the quality control of pharmaceutical products. In recent years, to ensure the quality of biological products and improve the research and development (R& D) of new biological drugs and vaccines, NIFDC conducted a series of regulatory science studies on key technologies for quality control and evaluation, and established a quality control and evaluation platform for biological drugs and vaccines. These studies accelerated the R&D of the biological drugs and vaccines in China and assured their safety and efficacy. In this paper, NIFDC's duties and achievements in the biological drug and vaccine field are summarized.
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页数：4
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共 32 条
[1]   Development of a Vero cell DNA reference standard for residual DNA measurement in China [J].
Cao, Shouchun ;
Dong, Guanmu ;
Tang, Jianrong ;
Li, Jia ;
Liu, Jinghua ;
Shi, Leitai ;
Li, Changgui ;
Wang, Junzhi .
HUMAN VACCINES & IMMUNOTHERAPEUTICS, 2013, 9 (02) :413-419
[2]   Universal antibodies and their applications to the quantitative determination of virtually all subtypes of the influenza A viral hemagglutinins [J].
Chun, Stella ;
Li, Changgui ;
Van Domselaar, Gary ;
Wang, Junzhi ;
Farnsworth, Aaron ;
Cui, Xiaoyu ;
Rode, Harold ;
Cyr, Terry D. ;
He, Runtao ;
Li, Xuguang .
VACCINE, 2008, 26 (48) :6068-6076
[3]   A global regulatory science agenda for vaccines [J].
Elmgren, Lindsay ;
Li, Xuguang ;
Wilson, Carolyn ;
Ball, Robert ;
Wang, Junzhi ;
Cichutek, Klaus ;
Pfleiderer, Michael ;
Kato, Atsushi ;
Cavaleri, Marco ;
Southern, James ;
Jivapaisarnpong, Teeranart ;
Minor, Philip ;
Griffiths, Elwyn ;
Sohn, Yeowon ;
Wood, David .
VACCINE, 2013, 31 :B163-B175
[4]  
Fang HH, 2009, PROG MICROBIOL IMMUN, V37, P8
[5]   Development and calibration of a standard for the protein content of granulocyte colony-stimulating factor products [J].
Gao, Kai ;
Rao, Chunming ;
Tao, Lei ;
Han, Chunmei ;
Shi, Xinchang ;
Wang, Lan ;
Fan, Wenhong ;
Yu, Lei ;
Wang, Junzhi .
BIOLOGICALS, 2012, 40 (02) :151-157
[6]  
Gao Qiang, 2008, Chinese Journal of Biologicals, V21, P60
[7]   Bioactivity Determination of Native and Variant Forms of Therapeutic Interferons [J].
Larocque, Louise ;
Bliu, Alex ;
Xu, Ranran ;
Diress, Abebaw ;
Wang, Junzhi ;
Lin, Rongtuan ;
He, Runtao ;
Girard, Michel ;
Li, Xuguang .
JOURNAL OF BIOMEDICINE AND BIOTECHNOLOGY, 2011,
[8]   Application of deglycosylation and electrophoresis to the quantification of influenza viral hemagglutinins facilitating the production of 2009 pandemic influenza (H1N1) vaccines at multiple manufacturing sites in China [J].
Li, Changgui ;
Shao, Ming ;
Cui, Xiaoyu ;
Song, Yingli ;
Li, Juan ;
Yuan, Liyong ;
Fang, Hanhua ;
Liang, Zhenglun ;
Cyr, Terry D. ;
Li, Fengxiang ;
Li, Xuguang ;
Wang, Junzhi .
BIOLOGICALS, 2010, 38 (02) :284-289
[9]   A simple slot blot for the detection of virtually all subtypes of the influenza A viral hemagglutinins using universal antibodies targeting the fusion peptide [J].
Li, Changgui ;
Jaentschke, Bozena ;
Song, Yingli ;
Wang, Junzhi ;
Cyr, Terry D. ;
Van Domselaar, Gary ;
He, Runtao ;
Li, Xuguang .
NATURE PROTOCOLS, 2010, 5 (01) :14-19
[10]   An Inactivated Enterovirus 71 Vaccine in Healthy Children [J].
Li, Rongcheng ;
Liu, Longding ;
Mo, Zhaojun ;
Wang, Xuanyi ;
Xia, Jielai ;
Liang, Zhenglun ;
Zhang, Ying ;
Li, Yanping ;
Mao, Qunying ;
Wang, Jingjing ;
Jiang, Li ;
Dong, Chenghong ;
Che, Yanchun ;
Huang, Teng ;
Jiang, Zhiwei ;
Xie, Zhongping ;
Wang, Lichun ;
Liao, Yun ;
Liang, Yan ;
Nong, Yi ;
Liu, Jiansheng ;
Zhao, Hongling ;
Na, Ruixiong ;
Guo, Lei ;
Pu, Jing ;
Yang, Erxia ;
Sun, Le ;
Cui, Pingfang ;
Shi, Haijing ;
Wang, Junzhi ;
Li, Qihan .
NEW ENGLAND JOURNAL OF MEDICINE, 2014, 370 (09) :829-837
1234