Hybridization analysis for the quantitative determination of residual DNA in some recombinant proteins expressed in E. coli cells'

Bollettino Chimico Farmaceutico

Volumn 135, Issue 5, 1996, Pages 287-296

  Facchetti, I ^a   Schito, S ^a   Vigevani, A ^a  

^a PFIZER INC   (United States)

Author keywords

nucleic acid hybridization assay; purity determination; recombinant proteins

Indexed keywords

BASIC FIBROBLAST GROWTH FACTOR; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; PROUROKINASE;

ARTICLE; CELL CULTURE; DNA DETERMINATION; DNA HYBRIDIZATION; DRUG PURITY; DRUG QUALITY; ESCHERICHIA COLI; PROTEIN ANALYSIS; RECOMBINANT DNA TECHNOLOGY; TECHNIQUE;

DNA; ESCHERICHIA COLI; HUMANS; NUCLEIC ACID HYBRIDIZATION; RECOMBINANT PROTEINS;

EID: 0029859360     PISSN: 00066648     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (30)

1. "Guidelines for Assuring the Quality of Pharmaceutical Preparations Made by Recombinant DNA Technology", WHO Technical Report, Series 747, 1987.
2. "Points to Consider in the Manufacture and Testing of Monoclonal Antibodies Products for Human Use",The Center of Biologics Evaluation and Research, United States Food and Drug Administration, 1987.
3. "Points to Consider in the Production and Testing of New Drugs and Biologics Produced by Recombinant DNA Technology", The Center of Biologics Evaluation and Research, United States Food and Drug Administration, 1985.
4. J. Briggs and P. Panfili, Anal.Chem. 63, 850 (1991).
5. M.L.M. Anderson and B.D. Young in "Nucleic Acid Hybridization: a Practical Approach", B.D. Hames and S.J. Higgings Eds., IRL Press, Oxford, England, 1985.
6. L.C. Eaton J. Pharm. Biom. Anal. 7, 5, 633 (1989).
7. T. Yoneyama, Qi Zibai and T. Miyamura J. Biol. Stand. 17, 371 (1989).
8. A. Isacchi, P. Caccia, F. Bertolero, L. Bergonzoni, F. Roletto, R. Ziliotto, L. Garofano, C. Jacob, P. Sarmientos, G. Mazuè, P. Carminati and R. Roncucci Chimica oggi, June, 72 (1990).
9. G. Orsini, A. Brandazza, P. Sarmientos, A. Molinari, J. Lansen, and G. Cauet Eur. J. Biochem. 195, 691 (1991).
10. S.C. Clark and R. Kamen Science 236, 1229 (1987).
11. K. Murray and N.E. Murray J. Mol. Biol. 98, 551 (1975).
12. T. Maniatis, E.F. Fritsh, J. Sambrook «Molecular cloning: a laboratory manual», Cold Spring Harbor Laboratory, Cold Spring Harbor, NY 1989.
13. J.A. McKeating, W. Al-Nakib, P.J. Greenaway, P.D. Griffiths J. Virol. Meth. 11, 207 (1975).
14. J. Bresser and D. Gillespie Anal. Biochem. 129, 357 (1983).
15. S.P. Bhat Anal. Biochem. 184, 59 (1990).
16. A.P. Feinberg and B. Vogelstein Anal. Biochem. 132, 6 (1983).
17. P.W. Rigby, M. Dieckmann, C. Rhodes, P. Berg J. Mol. Biol. 113, 237 (1977)
18. J.A. Matthews Anal. Biochem. 169, 1 (1988).
19. J.A. Rafalski Anal. Biochem. 173, 383 (1988).
20. J. Meinkoth, G. Whal Anal.Biochem. 138, 267 (1984).
21. K.C. Reed, D.A. Mann Nucl. Acids Res. 13, 7207 (1985).
22. R.M. Amasino Anal.Biochem. 152, 304 (1986).
23. A. Grimes, H.J. McArdle, F.B. Mercer Anal. Biochem. 172, 43/6 (1988).
24. J. Reiser, J. Renart, G.R. Stark Biochem. Biophys. Res. Comm. 85, 1104 (1978).
25. W.S. Riggsby Biochemistry 8, 222 (1969).
26. P.S. Thomas Proc. Natl. Acad. Sci. 77, 5201 (1980).
27. R.A. Laskey Methods Enzymol. 65, 363 (1980).
28. USP XXII 1992; paragraph 1225: 1710-1712.
29. L.M. Schwartz Anal.Chem. 51, 723 (1979).
30. R. McCormick Anal.Biochem 181, 66 (1989).