- Elmgren L, Li X, Wilson C et al.A global regulatory science agenda for vaccines. Vaccine2013;31 Suppl 2: B163–B175.
- Larocque L, Bliu A, Xu R et al.Bioactivity determination of native and variant forms of therapeutic interferons. J Biomed Biotechnol2011;2011: 174615.
- Yu L, Rao C, Shi X et al.A novel bioassay for the activity determination of therapeutic human brain natriuretic peptide (BNP). PLoS One2012;7: e49934.
- Cao S, Dong G, Tang J et al.Development of a Vero cell DNA reference standard for residual DNA measurement in China. Hum Vaccin Immunother2013;9: 413–419.
- Wang L, Rao C, Gao K et al.Development of a reference standard of Escherichia coli DNA for residual DNA determination in China. PLoS One2013;8: e74166.
- Gao K, Rao C, Tao L et al.Development and calibration of a standard for the protein content of granulocyte colony-stimulating factor products. Biologicals2012;40: 151–157.
- Shao M, Gao Q, Zhang ZS et al.[Stability of pandemic influenza vaccine virus strain NIBRG-14 during sub-culture.] Chin J Biol2009;22: 775–778.Chinese.
- Fang HH, Yuan LY, Shao M et al.Quality control of H1Nl influenza vaccine seed virus. Prog in Microbiol Immunol2009;37: 8–10.
- Li C, Shao M, Cui X et al.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. Biologicals2010;38: 284–289.
- Shao M, Li J, Song YL et al.[Development and validation of alternative method for determination of haemagglutinin content in influenza vaccine.] Chin J Biol2010;23: 103–106.Chinese.
- Chun S, Li C, van Domselaar G et al.Universal antibodies and their applications to the quantitative determination of virtually all subtypes of the influenza A viral hemagglutinins. Vaccine2008;26: 6068–6076.
- Li C, Jaentschke B, Song Y et al.A simple slot blot for the detection of virtually all subtypes of the influenza A viral hemagglutinins using universal antibodies targeting the fusion peptide. Nat Protoc2010;5: 14–19.
- Gao Q, Li CG, Liu SZ et al.[Development of a method for determination of hemagglutinin content in pandemic influenza vaccine containing aluminium adjuvant.] Chin J Biol2008;21: 60–61.Chinese.
- Stephenson I, Heath A, Major D et al.Reproducibility of serologic assays for influenza virus A (H5N1). Emerg Infect Dis2009;15: 1252–1259.
- Lin J, Zhang J, Dong X et al.Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: a phase I randomised controlled trial. Lancet2006;368: 991–997.
- Wu J, Liu SZ, Dong SS et al.Safety and immunogenicity of adjuvanted inactivated split-virion and whole-virion influenza A (H5N1) vaccines in children: a phase I–II randomized trial. Vaccine2010;28: 6221–6227.
- Zhu FC, Wang H, Fang HH et al.A novel influenza A (H1N1) vaccine in various age groups. N Engl J Med2009;361: 2414–2423.
- Wu J, Li W, Wang HQ et al.A rapid immune response to 2009 influenza A(H1N1) vaccines in adults: a randomized, double-blind, controlled trial. J Infect Dis2010;202: 675–680.
- Liang XF, Wang HQ, Wang JZ et al.Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet2010;375: 56–66.
- Mao Q, Li N, Yu X et al.Antigenicity, animal protective effect and genetic characteristics of candidate vaccine strains of enterovirus 71. Arch Virol2012;157: 37–41.
- Mao Q, Cheng T, Zhu F et al.The cross-neutralizing activity of enterovirus 71 subgenotype c4 vaccines in healthy Chinese infants and children. PLoS One2013;8: e79599.
- Liang ZL, Mao QY, Gao Q et al.Establishing China's national standards of antigen content and neutralizing antibody responses for evaluation of enterovirus 71 (EV71) vaccines. Vaccine2011;29: 9668–9674.
- Wang X, Peng W, Ren J et al.A sensor–adaptor mechanism for enterovirus uncoating from structures of EV71. Nat Struct Mol Biol2012;19: 424–429.
- Ren J, Wang X, Hu Z et al.Picornavirus uncoating intermediate captured in atomic detail. Nat Commun2013;4: 1929.
- Mao Q, Dong C, Li X et al.Comparative analysis of the immunogenicity and protective effects of inactivated EV71 vaccines in mice. PLoS One2012;7: e46043.
- Wu X, Mao Q, Yao X et al.Development and evaluation of a pseudovirus-luciferase assay for rapid and quantitative detection of neutralizing antibodies against enterovirus 71. PLoS One2013;8: e64116.
- Mao QY, He P, Yu X et al.[Laboratory evaluation of method for determination of neutralizing antibody against human enterovirus 71.] Chin J Biol2010;23: 885–888.Chinese.
- Zhu F, Xu W, Xia J et al.Efficacy, safety, and immunogenicity of an enterovirus 71 vaccine in China. N Engl J Med2014;370: 818–828.
- Zhu FC, Meng FY, Li JX et al.Efficacy, safety, and immunology of an inactivated alum-adjuvant enterovirus 71 vaccine in children in China: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet2013;381: 2024–2032.
- Li R, Liu L, Mo Z et al.An inactivated enterovirus 71 vaccine in healthy children. N Engl J Med2014;370: 829–837.
- McMinn PC.Enterovirus vaccines for an emerging cause of brain-stem encephalitis. N Engl J Med2014;370: 792–794.
- Mao Q, Wang Y, Gao R et al.A neonatal mouse model of coxsackievirus a16 for vaccine evaluation. J Virol2012;86: 11967–11976.
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Regulatory science accelerates the development of biotechnology drugs and vaccines by NIFDC
Zhenglun LiangNational Institutes for Food and Drug Control, Beijing 100050, China
, Qunying MaoNational Institutes for Food and Drug Control, Beijing 100050, China
, Yiping WangNational Institutes for Food and Drug Control, Beijing 100050, China
, Changgui LiNational Institutes for Food and Drug Control, Beijing 100050, China
, Kai GaoNational Institutes for Food and Drug Control, Beijing 100050, China
& Junzhi WangNational Institutes for Food and Drug Control, Beijing 100050, ChinaCorrespondence[email protected]
Pages 1-4
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Received 23 Sep 2015, Accepted 02 Nov 2015, Published online: 25 Jan 2019
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