Characterization and identification of alanine to serine sequence variants in an IgG4 monoclonal antibody produced in mammalian cell lines

Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences

Volumn 908, Issue , 2012, Pages 1-8

  Fu, Jinmei ^a   Bongers, Jacob ^a   Tao, Li ^a   Huang, Dan ^a   Ludwig, Richard ^a   Huang, Yunping ^a   Qian, Yueming ^a   Basch, Jonathan ^a   Goldstein, Joel ^a   Krishnan, Ramji ^a   You, Li ^a   Li, Zheng Jian ^a   Russell, Reb J ^a  

^a BRISTOL MYERS SQUIBB   (United States)

Author keywords

High performance liquid chromatography; Monoclonal antibody; Peptide mapping; Sequence variant; Tandem mass spectrometry

Indexed keywords

CELL BANKS; DIFFERENT SCALE; DNA SEQUENCING; FLUORESCENCE DETECTION; ION CURRENTS; LIGHT CHAIN; LOW LEVEL; MAMMALIAN CELL LINES; PEPTIDE MAPPING; ROOT CAUSE; SEQUENCE VARIANTS; SYNTHETIC PEPTIDE; TANDEM MASS SPECTROMETRY; TRYPTIC PEPTIDES; TYROSINE RESIDUES;

CELL CULTURE; CHROMATOGRAPHY; DNA SEQUENCES; ENCODING (SYMBOLS); HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MONOCLONAL ANTIBODIES; PEPTIDES;

AMINO ACIDS;

ALANINE; COMPLEMENTARY DNA; IMMUNOGLOBULIN G ANTIBODY; IMMUNOGLOBULIN G4 MONOCLONAL ANTIBODY; SERINE; UNCLASSIFIED DRUG;

AMINO ACID SEQUENCE; ANIMAL CELL; ANTIBODY PRODUCTION; ARTICLE; CONTROLLED STUDY; DNA SEQUENCE; FEMALE; FLUORESCENCE ANALYSIS; MAMMAL CELL; NONHUMAN; PRIORITY JOURNAL; TANDEM MASS SPECTROMETRY; ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY; ULTRAVIOLET RADIATION;

ALANINE; AMINO ACID SEQUENCE; ANIMALS; ANTIBODIES, MONOCLONAL; CHO CELLS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CRICETINAE; CRICETULUS; DNA, COMPLEMENTARY; HUMANS; IMMUNOGLOBULIN G; MOLECULAR SEQUENCE DATA; PEPTIDE FRAGMENTS; PEPTIDE MAPPING; SERINE; TANDEM MASS SPECTROMETRY; TRYPSIN;

MAMMALIA;

EID: 84867455878     PISSN: 15700232     EISSN: 1873376X     Source Type: Journal    
DOI: 10.1016/j.jchromb.2012.09.023     Document Type: Article

References (37)

1. Wan M., Shiau F.Y., Gordon W., Wang G.Y. Biotechnol. Bioeng. 1999, 62:485.
2. Harris R.J., Murnane A.A., Utter S.L., Wagner K.L., Cox E.T., Polastri G.D., Helder J.C., Sliwkowski M.B. Nat. Biotechnol. 1993, 11:1293.
3. Dorai H., Sauerwald T., Campbell A., Kyung Y.S., Goldstein J., Magill A., Lewis M.J., Tang Q.M., Jan D., Ganguly S., Moore G. BioProcess Int. 2007, 5:66.
4. Guo D., Gao A., Michels D.A., Feeney L., Eng M., Chan B., Laird M.W., Zhang B., Yu X.C., Joly J., Snedeco B., Shen A. Biotechnol. Bioeng. 2010, 107:163.
5. Yu X.C., Borisov O.V., Alvarez M., Michels D.A., Wang Y.J., Ling V. Anal. Chem. 2009, 81:9282.
6. Wen D., Vecchi M.M., Gu S., Su L., Dolnikova J., Huang Y., Foley S.F., Garber E., Pederson N., Meier W. J. Biol. Chem. 2009, 284:32686.
7. Ren D., Zhang J., Pritchett R., Liu H., Kyauk J., Luo J., Amanullah A. J. Chromatogr. B 2011, 879:2877.
8. Que A.H., Zhang B., Yang Y., Zhang J., Derfus G., Amanullah A. BioProcess Int. 2010, 8:52.
9. Lebkowski J.S., Dubridge R.B., Antell E.A., Greisen K.S., Calos M.P. Mol. Cell. Biol. 1984, 4:1951.
10. Parker J. Microbiol. Rev. 1989, 53:273.
11. Langridge J. Aust. J. Biol. Sci. 1974, 27:309.
12. Nene V., Glass R.E. Mol. Gen. Genet. 1984, 194:166.
13. Knowles J.R. Science 1987, 236:1252.
14. Cupples C.G., Miller J.H. Genetics 1988, 120:637.
15. Harris R.J. Dev. Biol. 2005, 122:117.
16. International Conference on Harmonization (ICH), Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, 1999, August.
17. Committee on Process Development and Manufacturing, Biotechnology Division, Biological Section, Pharmaceutical Manufacturers Association BioPharm. Int. 1991, 4:22.
18. Ahrer K., Jungbauer A. J. Chromatogr. B 2006, 841:110.
19. Wada Y. J. Chromatogr. B 2002, 781:291.
20. Allen D., Baffi R., Bausch J., Bongers J., Costello M., Dougherty J., Federici M., Garnick R., Peterson S., Riggins R., Sewerin K., Tuls J. Biologicals 1996, 24:255.
21. Yuan P.M., Ryan D.E., Levin W., Shively J.E. Proc. Natl. Acad. Sci. U.S.A. 1983, 80:1169.
22. Kaneko R., Wada Y., Hisada M., Naoki H., Matsuo T. J. Chromatogr. B 1999, 731:125.
23. Lim A., Prokaeva T., McComb M.E., O'Connor P.B., Théberge R., Connors L.H., Skinner M., Costello C.E. Anal. Chem. 2002, 74:741.
24. Tanaka K., Takenaka S., Tsuyama S., Wada Y. J. Am. Soc. Mass Spectrom. 2006, 17:508.
25. Yang Y., Strahan A., Li C., Shen A., Liu H., Ouyang J., Katta V., Francissen K., Zhang B. mAbs 2010, 2:285.
26. Gatlin C.L., Eng J.K., Cross S.T., Detter J.C., Yates J.R. Anal. Chem. 2000, 72:757.
27. Wada Y. Biol. Mass Spectrom. 1992, 21:617.
28. Dayhuff T.J., Atkins J.F., Gesteland R.F. J. Biol. Chem. 1986, 261:7491.
29. Bruce A.G., Atkins J.F., Gesteland R.F. Proc. Natl. Acad. Sci. U.S.A. 1986, 83:5062.
30. Guo M., Chong Y.E., Shapiro R., Beebe K., Yang X.-L., Schimmel P. Nature 2009, 462:808.
31. Beebe K., Mock M., Merriman E., Schimmel P. Nature 2008, 451:90.
32. Fillingame R.H., Oldenburg M., Fragas D. J. Biol. Chem. 1991, 266:20934.
33. Saul B., Schmiedenb V., Kling C., Mülhardt C., Gassay P., Kuhseb J., Beckera C.-M. FEBS Lett. 1994, 350:71.
34. Yu L., Remmele R.L., He B. Rapid Commun. Mass Spectrom. 2006, 20:3674.
35. Zhang Z., Pan H., Chen X. Mass Spectrom. Rev. 2009, 28:147.
36. Liu H., Gaza-Bulsec G., Faldu D., Chumsae C., Sun J. J. Pharm. Sci. 2008, 97:2426.
37. Khetan A., Huang Y.-M., Dolnikova J., Pederson N.E., Wen D., Yusuf-Makagiansar H., Chen P., Ryll T. Biotechnol. Bioeng. 2010, 107:116.