Диссертация (1091787), страница 26
Текст из файла (страница 26)
// М.: Группа компаний Виалек. – 2001. – T.23. – 2014.– 2001. – V.23. – 472 p.38. HACCP: Introducing the Hazard Analysis and Critical Control Point System. Geneva, WorldHealth Organization, 1997 (document WHO/FSF/FOS/97.2). WHO Technical Report Series No908, 2003, Annex 7 Application of Hazard Analysis and Critical Control Point (HACCP)methodology to pharmaceuticals.//[http://www.who.int]39.
Food and Drug Administration (FDA) Guidance for industry: General Principles andPractices. – 201140.Ассоциациявалидациироссийскихметодиканализафармацевтическихлекарственныхпроизводителей.средств//М.:РуководствопоФармацевтическаяпромышленность. Утверждено и введено в действие решением общего собрания членовАссоциации Российских фармацевтических производителей от 10.08.2007, протокол №55.41. Аладышева Ж.И., Береговых В.В., Мешковский А.П., Левин Л.М..
Основныепринципы проведения валидации на фармацевтическом производстве // М.: Русский врач.– 2005. – 186 с.42. ICH Q2A Validation of analitical procedures: definition and terminology // ICH. – 200543. ICH Q2B Validation of analitical procedures: methodology // ICH. – 200544. WHO Expect Committe on specification for pharmaceutical preparation. Validation ofanalitical prosedures used in the examination of pharmaceutical materials // WHO. – 201145.
Food and Drug Administration (FDA) Guidance for industry: Bioanalitical method validation//FDA. – 200146. European Medicines Agency (EMA) Guideline on bioanalitical method validation // EMA. –201112347. Meeting Report WHO Study Group on Cell Substrates for Production of Biologicals //WHO. Geneva. – 200748. Acceptability of cell substrates for production of biologicals. Report of a WHO Study Group.// WHO. Geneva. – 1987. – No 74749. WHO Expert Committee on Biological Standardization. Fortyseventh Report // WHO.Geneva.
– 1998. – No. 87850. Hui Cai, Xuelin Gu, Mary S. Scanlan, Dintletse Ramatlapeng, Chris R. Lively Developmentof a qPCR assay for quantitation of residual mouse DNA and comparison of four samplepurification methods for DNA isolation // Biopharmaceutical Services, PPD Inc., 8551 ResearchWay, Middleton, WI 53562, United States51. Wang X., Morgan D.M., Wang G., Mozier N.M. Residual DNA analysis in biologicsdevelopment: review of measurement and quantitation technologies and future directions / WileyPeriodicals, Inc. – 201152. Robertson J.S., Heath A.B. A collaborative study to examine the sensitivity andreproducibility of assays for the detection of DNA in biologicals derived from continuous celllines // Biologicals.
– 1992. – V20 (1). – P.73-8153. Center for Biologics Evaluation and Research. Points to Consider in the Manufacture andTesting of Monoclonal Antibody Products for Human Use // FDA. – 199754. Lovatt A. Applications of Quantitative PCR in the Biosafety and Genetic StabilityAssessment of Biotechnology Products. // Rev.
Mol. Biotechnol. – 2002. – V.82. – P.279–30055. Wolter T. and Richter A. Assays for Controlling Host-Cell Impurities in Biopharmaceuticals// BioProcess International. – 2005. – V.2. – P. 40-4656. Barnard T., Robertson C., Jagals P. and Potgieter A. rapid and low-cost DNA extractionmethod for isolating Escherichia coli DNA from animal stools // African Journal ofBiotechnology. – 2011.
– V. 10(8), P.1485-149057. Nelson E.A., Palombo E.A., Knowles S.R., Comparison of methods for the extraction ofbacterial DNA from human faecal samples for analysis by real-time PCR. Current Research,Technology and Education Topics in Applied Microbiology and Microbial Biotechnology. –201058.
Hurley J.C. Endotoxemia: methods of detection and clinical correlates// Clin Microbiol Rev.– 1995. – V.8. – P.268–29259. Williams K.L. Drugs and pharmaceutical sciences, endotoxins: pyrogens LAL testing anddepyrogenation // Marcel Dekker Inc. – 2007. – V. 167. – 440 p.12460. Brykova N.S., Gusarov D.A., Sokolova I.V., Gusarova V.D., Vorobjeva T.V., BairamashviliD.I. Development of the downstream process in the production of the recombinant histone H1.3variant // Process Biochemistry.
– 2011. – V.46. P.2036–204361. Kleppe K., Othsura E., Kleppe R., Molineux I., Khorana H.G. Studies on polynucleotides.XCVI. Repair replication of short synthetic DNA’s as catalysed by DNA polymerases // J MolBiol. – 1971. – V.56. – P.341-36162. Ребриков Д.В., Саматов Г.А., Трофимов Д.Ю. ПЦР «в реальном времени» // М.:БИНОМ. Лаборатория знаний. – 2009. – 215 с.63. Гэд Ш.К. Производство лекарственных средств.
Контроль качества и регулирование.Практическое руководство: пер. с англ. Под ред. Береговых В.В. // СПб.: ЦОП«Профессия». – 2013. – 960 с.64.СтандартнаяоперационнаяпроцедураСОП-КО-3000-905-02«Идентификацияфрагментов ДНК методом горизонтального электрофореза в агарозном геле» // ОБП ИБХРАН. – 200965.
Higuchi R., Dollinger G., Walsh P.S., Griffith R. Simultaneous amplification and detectionof specific DNA sequences // Biotechnology. – 1992. – V.10. – P.413-41766. Higuchi R., Fockler C., Dollinger G., Watson R. Kinetic PCR: Real time monitoring of DNAamplification reactions // Biotechnology. – 1993. – V.11. – P.1026 - 1030.67. Peper G., Fankhauser A., Merlin T., Roscic A., Hoffman M., Obrdlik P. Direct real-timequantitative PCR for measurement of host-cell residual DNA in therapeutic proteins// Journal ofPharmaceutical and Biomedical Analysis. – 2014. – V.100. – P.123-13068. Hu B., Sellers J., Kupec J., Ngo W., Fenton S., Yang T., Grebanier A. Optimization andvalidation of DNA extraction and real-time PCR assay for the quantitative mearsument ofresidual host cell DNA in biopharmaceutical products// Journal of Pharmaceutical andBiomedical Analysis.
– 2014. – V. 88. – P.92-9569. Nissom P. Specific detection of residual CHO host cell DNA by real-time PCR// Biologicals.– 2007. – V.35. – P.211-21570. Chang J., Chen Y., Chou Y., Wang R. Quantitative detection of residual porcine host cellDNA by real-time PCR // Biologicals. – 2014. – V. 42. – P.74-7871. Sairi R.K., Scharf S., Faloona F., Mullis K.B., Horn G.T., Erlich H.A., Arneim N. Enzymaticamplification of beta-globin genomic sequences and restriction site analysis for diagnosis ofsickle cell anemia // Science. – 1985. – V.230. – P.1350-1354.72. Witcombe D., Bronie J., Gillard H.L., McKechnie D., Theaker J., Newton C.R., Little S.A.Homogeneous fluorescence assay for PCR amplicons: its application to real-time, single-tubegenotyping // Clin Chem.
– 1998. – V.44. – P.918-92312573. Witcombe D., Theaker J., Guy S.P., Brown T., Little S. Detection of PCR products usingself-probing amplicons and fluorescence // Nat. Biotechnol. – 1999. – V.17. – P.804-80774. Thelwell N, Millingtone S, Solinas A, Booth J, Brown T. Mode of action and application ofScorpion primers to mutation detection // Nucleic Acids Res. – 2000. – V.28. – P.3752-376175.
Bates J.A., Taylor Е.J.A. Scorpion ARMS primers for SNP real-time PCR detection andquantification of Pyrenophora teres // Molecular Plant Pathology. – 2001. – V.2. – P.275-28076. Solinas A., Brown L.G., McKeen C., Mellor J.M., Nicol J., Thelwell N., Brown T. DuplexScorpion primers in SNP analysis and FRET application // Nucleic Acids Res. – 2001.
– V.29(20). – P.1-977. Kong D.M., Shen H.X., Mi H.F. Detection of Hepatitis В Virus DNA by Duplex ScorpionPrimer-based PCR Assay // Chinese Journal of Chemistry. – 2004. – V. 22. – P.903-90778. Li Q., Luan G., Guo Q., Liang J. A new class of homogeneous nucleic acid probes basedon specific displacement hybridization // Nucleic Acids Res. – 2002. – V.30(2):e5.79.
Holland P.M., Abramson R.D., Watson R., Gelfand, D.H. Detection of specificpolymerase chain reaction product by utilizing the 5'-3' exonuclease activity of Thermusaquaticus DNA polymerase // Proc Natl Acad Sci U S A., – 1991. – V. 88. P.7276-728080. Livak K.J. SNP genotyping by the 5'-nuclease reaction // Methods Mol.
Biol. – 2003. –V.212. – P.129-14781. Happich D., Madlener K., Schwaab R. Application of the TaqMan-PCR for genotypingof the prothrombin G20210A mutation and of the thermolabile methylenetetrahydrofolatereductase mutation // ThrombHaemost. – 2000. – V. 84. P.144-14582. Kostrikis L.G., Tyagi S., Mhlanga M.M., Ho D.D., Kramer F.R. Spectral genotypingof human alleles // Science. – 1998. – V. 279. – P.1228-122983.
Bonnet G., Tyagi S., Libchaber A., Kramer F.R. Thermodynamic basis of the enhancedspecificity of structured DNA probes // Proc Natl Acad Sci USA. – 1999. – V. 96. – P.6171-617684. Marras S.A., Kramer F.R., Tyagi S. Genotyping SNPs with molecular beacons //Methods Mol Biol. – 2003. – V. 212. – P.111-12885. Didenko V.V. DNA probes using fluorescence resonance energy transfer (FRET): designsand applications // Biotechniques. – 2001.