Development of a quantitative PCR assay for residual mouse DNA and comparison of four sample purification methods for DNA isolation

Journal of Pharmaceutical and Biomedical Analysis

Volumn 55, Issue 1, 2011, Pages 71-77

  Cai, Hui ^a   Gu, Xuelin ^a   Scanlan, Mary S ^a   Lively, Chris R ^a  

^a Pharmaceutical Product Development   (United States)

Author keywords

DNA isolation; DNA quantitation; Host cell DNA; Quantitative PCR; Real time PCR

Indexed keywords

CHLOROFORM; GENOMIC DNA; GLYCOGEN; IMMUNOGLOBULIN G ANTIBODY; PHENOL;

ARTICLE; CONTROLLED STUDY; DNA EXTRACTION; DNA ISOLATION; DNA PURIFICATION; GENE AMPLIFICATION; GENE TARGETING; MOUSE; NONHUMAN; POLYMERASE CHAIN REACTION; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS;

ALGORITHMS; ANIMALS; ANTIBODIES, MONOCLONAL; DNA; DRUG CONTAMINATION; IMMUNOGLOBULIN G; LIMIT OF DETECTION; MICE; MICROCHEMISTRY; POLYMERASE CHAIN REACTION; RECOMBINANT PROTEINS; REPETITIVE SEQUENCES, NUCLEIC ACID; REPRODUCIBILITY OF RESULTS; TECHNOLOGY, PHARMACEUTICAL;

EID: 79951774762     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2011.01.010     Document Type: Article

References (17)

1. FDA Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use 1997, US Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, February.
2. WHO Acceptability of cell substrates for production of biologicals. Teth. Rep. Ser. 1987, 747:1-29.
3. WHO WHO Expert Committee on Biological Standardization. Teth. Rep. Ser. 1998, 878:1-101.
4. EU Position Statement on the Use of Tumourigenic Cells of Human Origin for the Production of Biological and Biotechnological Medicinal Products 2001, The European Agency for the Evaluation of Medicinal Products: Evaluation of Medicinal Products for Human Use, CPMP/BWP/1143/00.
5. Israel M.A., Chan H.W., Hourihan S.L., Rowe W.P., Martin M.A. Biological activity of polyoma viral DNA in mice and hamsters. J. Virol. 1979, 29:990-996.
6. Petricciani J.C., Regan P.J. Risk of neoplastic transformation from cellular DNA: calculations using the oncogene model. Dev. Biol. Stand. 1987, 68:43-49.
7. Lee D.H., Bae J.E., Lee J.H., Shin J.S., Kim.F I.S. Quantitative detection of residual E. coli host cell DNA by real-time PCR. J. Microbiol. Biotechnol. 2010, 20:1463-14670.
8. Strachan T., Read A.P. Nucleic acid hybridization assays. Human Molecular Genetics 1999, Wiley-Liss, New York, pp. 95-119. 2nd ed.
9. Durrant I., Brunning S., Eccleston L., Chadwick P., Cunningham M. Fluorescein as a label for non-radioactive in situ hybridization. Histochem. J. 1995, 27:94-99.
10. Kung V.T., Panfili P.R., Sheldon E.L., King R.S., Nagainis P.A., Gomez B., Ross D.A., Briggs J., Zuk R.F. Picogram quantitation of total DNA using DNA-binding proteins in a silicon sensor-based system. Anal. Biochem. 1990, 187:220-227.
11. Lovatt A. Applications of quantitative PCR in the biosafety and genetic stability assessment of biotechnology products. J. Biotechnol. 2002, 82:279-300.
12. Shipley G.L. An introduction to real-time PCR. Real-time PCR 2006, 1-38. Taylor & Francis Group, New York. M.T. Dorak (Ed.).
13. http://www.idtdna.com/.
14. http://www.ncbi.nlm.nih.gov/sites/genome.
15. Waterston R.H., Lindblad-Toh K., Birney E., Rogers J., Abril J.F., Agarwal P., Agarwala R., Ainscough R., Alexandersson M., An P., Antonarakis S.E., Attwood J., Baertsch R., Bailey J., Barlow K., Beck S., Berry E., Birren B., Bloom T., Bork P., Botcherby M., Bray N., Brent M.R., Brown D.G., Brown S.D., Bult C., Burton J., Butler J., Campbell R.D., Carninci P., Cawley S., Chiaromonte F., Chinwalla A.T., Church D.M., Clamp M., Clee C., Collins F.S., Cook L.L., Copley R.R., Coulson A., Couronne O., Cuff J., Curwen V., Cutts T., Daly M., David R., Davies J., Delehaunty K.D., Deri J., Dermitzakis E.T., Dewey C., Dickens N.J., Diekhans M., Dodge S., Dubchak I., Dunn D.M., Eddy S.R., Elnitski L., Emes R.D., Eswara P., Eyras E., Felsenfeld A., Fewell G.A., Flicek P., Foley K., Frankel W.N., Fulton L.A., Fulton R.S., Furey T.S., Gage D., Gibbs R.A., Glusman G., Gnerre S., Goldman N., Goodstadt L., Grafham D., Graves T.A., Green E.D., Gregory S., Guigo R., Guyer M., Hardison R.C., Haussler D., Hayashizaki Y., Hillier L.W., Hinrichs A., Hlavina W., Holzer T., Hsu F., Hua A., Hubbard T., Hunt A., Jackson I., Jaffe D.B., Johnson L.S., Jones M., Jones T.A., Joy A., Kamal M., Karlsson E.K., et al. Initial sequencing and comparative analysis of the mouse genome. Nature 2002, 420:520-562.
16. Gallagher M.L., Burke W.F., Orzech K. Carrier RNA enhancement of recovery of DNA from dilute solutions. Biochem. Biophys. Res. Commun. 1987, 144:271-276.
17. Kishore R., Reef Hardy W., Anderson V.J., Sanchez N.A., Buoncristiani M.R. Optimization of DNA extraction from low-yield and degraded samples using the BioRobot EZ1 and BioRobot M48. J. Forensic Sci. 2006, 51:1055-1061.