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生物制剂中残余DNA的潜在危害性及其检测方法的研究进展 被引量：10

Progress in study on potential hazard and test method of residual DNA in biologics
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摘要 残余DNA(residual DNA,rDNA)的监控对多数已上市或正在开发的生物制剂都是必需的。rDNA被视为与宿主相关的不纯物,阐明其潜在的危害性,运用适当方法证明其在工艺过程中被清除到可接受和/或一致性的水平,对生物制剂生产和开发至关重要。本文就rDNA的潜在危害性及其定量检测方法的研究进展作一综述。 The monitoring of residual DNA（rDNA）is necessary to most of biologics in market and in development. The illustration of potential hazard of rDNA which is considered as a host-associated impurity and demonstration of removal of rDNAtoanacceptableand/orconsistentlevelsinbioprocessbyusingapplicablemethodsareveryimportanttothe production and development of biologics. This paper reviews the progress in study on of potential hazard and test method of residual DNA in biologics.
作者 张昀 陈兴
机构地区 北京天坛生物制品股份有限公司乙肝疫苗室
出处 《中国生物制品学杂志》 CAS CSCD 2014年第10期1348-1353,共6页 Chinese Journal of Biologicals
关键词 残余DNA 潜在危害性 检测方法 Residual DNA（rDNA） Potential risk Test method
分类号 R392.33 [医药卫生—免疫学]
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参考文献46

  • 1Wang X, Morgan DM, Wang G, et al. Residual DNA analysis in biologics development: review of measurement and quantitation technologies and future directions [J]. Biotechnol Bioeng, 2012, 109 (2): 307-317. 被引量：1
  • 2Li SF, Lewis AM Jr, Peden K. Issues associated with residual cell-substrate DNA in viral vaccines [J]. BMogicals, 2009, 37 (3): 190-195. 被引量：1
  • 3Venter CJ, Adams MD, Myers EW, et al. The sequence of the human genome [J]. Science, 2001, 291 (5507): 1304-1351. 被引量：1
  • 4Waterston RH, Lindblad-Toh K, Birney E, et al. Initial se- quencing and comparative analysis of the mouse genome [J]. NatUre, 2002, 420 (6915): 520-562. 被引量：1
  • 5Smit AF. Identification of a new, abundant superfamily of mammalian LTR-transposons [J]. Nucleic Acids Res, 1993, 21 (8): 1863-1872. 被引量：1
  • 6Smit AF, Riggs AD. Tiggers and DNA transposon fossils in the human genome [J]. Proc Natl Acad Sci USA, 1996, 93 (4): 1443-1448. 被引量：1
  • 7Smit AF, Toth G, Riggs AD, et al. Ancestral, mammalian- wide subfamilies of LINE-I repetitive sequences [J]. J Mol Biol, 1995, 246(3): 401-417. 被引量：1
  • 8Lovatt A. Applications of quantitative PCR in the biosafety and genetic stability assessment of biotechnology products [ J ]. J Bioteehnol, 2002, 82(3): 279-300. 被引量：1
  • 9Mehta S, Keer JT. Performanee charaeteristies of host-cell DNA quantification methods [J]. BioProcess Int, 2007, 10: 44-58. 被引量：1
  • 10Venable D, Miro-Quesada G, Calley J, et al. High-throughput and quantitative detection of residual NS0 and CHO host cell genomie DNA [Jl. BioProcess Int, 2007, 6: 56-61. 被引量：1

二级参考文献13

  • 1饶春明,赵阳,李永红,王军志.应用荧光法测定重组细胞因子中残余DNA含量[J].药物分析杂志,2005,25(12):1417-1419. 被引量：22
  • 2EU. Position statement on the use of tumorigenic cells of human origin for the production of biological and bioteehnological medicinal products. The European Agency for the Evaluation of Medieinal Products : Evaluation of medicinal products for human use. CPMP/BWP/1143/ 00 2001. 被引量：1
  • 3FDA. Points to consider in the manufacture and testing of monoclonal antibody products for human use. US Department of Health and Human Services,Food and Drug Administration, Center for Biologics Evaluation and Research 1997. 被引量：1
  • 4WANG Jun-zhi(王军志).Research & Development and Quality Control of Biotechnical Drugs(2nd Ed)(生物技术药物研究开发和质量控制)(第二版).Beijing(北京):Science Press(科学出版社),2007.98. 被引量：1
  • 5Singer VL, Jones LJ, Yue ST, et al. Characterization of PicoGreen reagent and development of a fluorescence - based solution assay for double - stranded DNA quantitation. Anal Biochem, 1997,249 ( 2 ) : 228. 被引量：1
  • 6.ChP(中国药典)2005．Vol Ⅲ(三部)[M].,.203. 被引量：1
  • 7RaoChun—ming(饶春明) Lizuo—gang(李佐刚) DingXi—shen(丁锡申).Detection of residual DNAin rhIFN—α1b by using biotin—lebaled probe（采用生物素探针检测rhIFN—α1b中外源DNA含量）[J].中国生物制品学杂志,1990,3:70-70. 被引量：1
  • 8Chadwick RB, Conrad MP, McGinnis MD ,et al. Heterozygote and mutation detection by direct automated fluorescent DNA sequencing using a mutant Taq DNA polymerase. Biotechniques. 1996 Apr;20 (4) :676. 被引量：1
  • 9Labarca C, Paigen K. A simple, rapid, and sensitive DNA assay procedure. Anal Biochem. 1980 Mar 1 ;102(2) :344. 被引量：1
  • 10Singer VL, Jones LJ, Yue ST et al. Characterization of Pico Green reagent and development of a fluorescence - based solution assay for double - stranded DNA quantitation. Anal Biochem. 1997 Jul 1 ; 249(2) :228. 被引量：1

共引文献39

同被引文献56

  • 1饶春明,赵阳,李永红,王军志.应用荧光法测定重组细胞因子中残余DNA含量[J].药物分析杂志,2005,25(12):1417-1419. 被引量：22
  • 2张婷婷,叶波平.包涵体蛋白质的复性研究进展[J].药物生物技术,2007,14(4):306-309. 被引量：25
  • 3罗惠霞,李敏,王玉炯.包涵体蛋白复性的几种方法[J].生物技术通报,2007,23(5):96-98. 被引量：25
  • 4Petricciani J, Knezevic I. Animal cell substrates for the production of biologicals: An introduction to WHO documents. Biologicals, 2014, pii:SI045-S1056. 被引量：1
  • 5World Health Organization. Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks. Replacement of annex 1, TRS, 878. technical report series 978, annex 3. http://www.who.int/biologicals/vaccincs/TRS 978 Annex_3.ixlt?ual. 被引量：1
  • 6Knezevic I1, Stacey G Petricciani J, et al. WHO Study Group on cell substrates for production of biologicals, Geneva, Switzerland, 11-12 June 2007. Biologicals, 2008, 36(3):203-211. 被引量：1
  • 7Knezevic I, Stacey Petricciani J, et al. Evaluation of cell substrates for the production of biologicals: Revision of WHO recommendations. Report of the WHO Study Group on Cell Substratcs for the Production of Biologicals, 22-23 April 2009, Bethesda, USA. Biologicals, 2010, 38(1):162-169. 被引量：1
  • 8Hussain M. A direct qPCR method for residual DNA quantification in monoclonal untibody drugs produced in CHO cells. J Pharm Biomed Anal, 2015, 115:603-606. 被引量：1
  • 9Peper G Fankhauser A, Merlin I", et al. Direct real-time quantitative PCR for measurement of host-cell residual DNA in therapeutic proteins. J Pharm Biomed Anal, 2014, I00:123-130. 被引量：1
  • 10Peden K, Sheng L, Pal A, et al. Biological activity of residual cell-substrate DNA. Dev Biol (Basel), 2006, 123:45=53; discussion 55-73. 被引量：1

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中国生物制品学杂志
2014年 第10期

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