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Review

New approaches for characterization of the genetic stability of vaccine cell lines

, &
Pages 1669-1672 | Received 15 Dec 2016, Accepted 10 Feb 2017, Published online: 23 Mar 2017

References

  • ATCC, Technical Bulletin 7, Passage Number Effects In Cell Lines. 2010
  • Hughes P, Marshall D, Reid Y, Parkes H, Gelber C. The costs of using unauthenticated, over-passaged cell lines: how much more data do we need? Biotechniques 2007; 43(5):575; PMID:18072586; https://doi.org/10.2144/000112598
  • World Health Organization, Replacement of Annex 1 of WHO Technical Report Series, No. 878, Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks. 2010
  • Food and Drug Administration, Center for Biologics Evaluation and Research Food and Drug Administration. Supplement to the Points to Consider in the Production and Testing of New Drugs and Biologic& Produced by Recombinant DNA Technology: Nucleic Acid Characterization and Genetic Stability. 1992
  • World Health Organization. Technical Report Series: biological products: general recommendations, Guidelines on evaluation of similar Biotherapeutic Products (SBPs), ECBS. 2009
  • Ph Eur, Monographs: Medicinal and Pharmaceutical Substances, Products of Recombinant DNA Technology. 2016
  • ICH Topic Q 5 B, Quality of Biotechnological Products: Analysis of the expression construct in cell lines used for production of rDNA derived protein products. 1996
  • Hughes ED, Qu YY, Genik SJ, Lyons RH, Pacheco CD, Lieberman AP, Samuelson LC, Nasonkin IO, Camper SA, Van Keuren ML, et al. Genetic variation in C57BL/6 ES cell lines and genetic instability in the Bruce4 C57BL/6 ES cell line. Mamm Genome 2007; 18(8):549-58; PMID:17828574; https://doi.org/10.1007/s00335-007-9054-0
  • Aumiller JJ, Mabashi-Asazuma H, Hillar A, Shi X, Jarvis DL. A new glycoengineered insect cell line with an inducibly mammalianized protein N-glycosylation pathway. Glycobiology 2012; 22(3):417-28; PMID:22042767; https://doi.org/10.1093/glycob/cwr160
  • Paakkanen R, Vauhkonen H, Eronen KT, Jarvinen A, Seppanen M, Lokki ML. Copy number analysis of complement C4A, C4B and C4A silencing mutation by real-time quantitative polymerase chain reaction. PLoS One 2012; 7(6):e38813; PMID:22737222; https://doi.org/10.1371/journal.pone.0038813
  • Castley AS, Martinez OP. Molecular analysis of complement component C4 gene copy number. Methods Mol Biol 2012; 882:159-71; PMID:22665233
  • Svec D, Tichopad A, Novosadova V, Pfaffl MW, Kubista M. How good is a PCR efficiency estimate: Recommendations for precise and robust qPCR efficiency assessments. Biomol Detect Quantif 2015; 3:9-16; PMID:27077029; https://doi.org/10.1016/j.bdq.2015.01.005
  • Azizi A, Aidoo F, Gisonni-Lex L, McNeil B. Determination of HSV-1 UL5 and UL29 gene copy numbers in an HSV complementing Vero cell line. J Biotechnol 2013; 168(4):382-7; PMID:24140636; https://doi.org/10.1016/j.jbiotec.2013.10.002
  • World Health Organization. Standard Operating Procedure Mutant Analysis by PCR and Restriction Enzyme Cleavage (MAPREC) for Oral Poliovirus (SABIN) Vaccine Types 1, 2 OR 3, Version 5. 2012
  • Adzitey F. Genetic diversity of Escherichia coli isolated from ducks and the environment using enterobacterial repetitive intergenic consensus. Pak J Biol Sci 2013; 16(20):1173-8; PMID:24506018; https://doi.org/10.3923/pjbs.2013.1173.1178
  • Yang L, Ding J, Zhang C, Jia J, Weng H, Liu W, Zhang D. Estimating the copy number of transgenes in transformed rice by real-time quantitative PCR. Plant Cell Rep 2005; 23(10-11):759-63; PMID:15459795; https://doi.org/10.1007/s00299-004-0881-0
  • Mantel N, Girerd Y, Geny C, Bernard I, Pontvianne J, Lang J, Barban V. Genetic stability of a dengue vaccine based on chimeric yellow fever/dengue viruses. Vaccine 2011; 29(38):6629-35; PMID:21745519; https://doi.org/10.1016/j.vaccine.2011.06.101
  • Flaherty P, Natsoulis G, Muralidharan O, Winters M, Buenrostro J, Bell J, Brown S, Holodniy M, Zhang N, Ji HP. Ultrasensitive detection of rare mutations using next-generation targeted resequencing. Nucleic Acids Res 2012; 40(1):e2; PMID:22013163; https://doi.org/10.1093/nar/gkr861
  • Xu F, Wang W, Wang P, Jun LM, Chung SP, Wang J. A fast and accurate SNP detection algorithm for next-generation sequencing data. Nat Commun 2012; 3:1258; PMID:23212387; https://doi.org/10.1038/ncomms2256
  • Treangen TJ, Salzberg SL. Repetitive DNA and next-generation sequencing: computational challenges and solutions. Nat Rev Genet 2011; 13(1):36-46; PMID:22124482
  • Liang A, Cao S, Han L, Yao Y, Moaeen-Ud-Din M, Yang L. Construction and evaluation of the eukaryotic expression plasmid encoding two copies of somatostatin genes fused with hepatitis B surface antigen gene S. Vaccine 2008; 26(23):2935-41; PMID:18455280; https://doi.org/10.1016/j.vaccine.2008.03.036
  • Ross TM, Xu Y, Bright RA, Robinson HL. C3d enhancement of antibodies to hemagglutinin accelerates protection against influenza virus challenge. Nat Immunol 2000; 1(2):127-31; PMID:11248804; https://doi.org/10.1038/77802
  • Quail MA, Smith M, Coupland P, Otto TD, Harris SR, Connor TR, Bertoni A, Swerdlow HP, Gu Y. A tale of three next generation sequencing platforms: comparison of Ion Torrent, Pacific Biosciences and Illumina MiSeq sequencers. BMC Genomics 2012; 13:341; PMID:22827831; https://doi.org/10.1186/1471-2164-13-341
  • Liu L, Li Y, Li S, Hu N, He Y, Pong R, Lin D, Lu L, Law M. Comparison of next-generation sequencing systems. J Biomed Biotechnol 2012; 2012:251364; PMID:22829749
  • Koren S, Schatz MC, Walenz BP, Martin J, Howard JT, Ganapathy G, Wang Z, Rasko DA, McCombie WR, Jarvis ED, et al. Hybrid error correction and de novo assembly of single-molecule sequencing reads. Nat Biotechnol 2012; 30(7):693-700; PMID:22750884; https://doi.org/10.1038/nbt.2280
  • Ng SH, Azizi A, Edamura K, Malott RJ, Charlebois RL, Logvinoff C, Schreiber M, Mallet L, Gisonni-Lex L. Preliminary evaluation of next-generation sequencing performance relative to qPCR and in vitro cell culture tests for Human Cytomegalovirus. PDA J Pharm Sci Technol 2014; 68(6):563-71; PMID:25475630; https://doi.org/10.5731/pdajpst.2014.01013

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