Evaluation of the iCE280 Analyzer as a potential high-throughput tool for formulation development

Journal of Pharmaceutical and Biomedical Analysis

Volumn 43, Issue 3, 2007, Pages 963-972

  Li, Ning ^a   Kessler, Kendall ^a   Bass, Laura ^a   Zeng, David ^a  

^a PFIZER INC   (United States)

Author keywords

Deamidation; iCE280 Analyzer; Imaged capillary isoelectric focusing; Pegylation; Protein

Indexed keywords

IMMUNOGLOBULIN G; LYSINE; SIALIC ACID;

ACIDITY; ANALYZER; ARTICLE; DEAMINATION; GLYCOSYLATION; ISOELECTRIC FOCUSING; LINEAR REGRESSION ANALYSIS; PRIORITY JOURNAL;

CARBOXYPEPTIDASE B; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG STABILITY; HUMAN GROWTH HORMONE; HYDROGEN-ION CONCENTRATION; IMMUNOGLOBULIN G; ISOELECTRIC FOCUSING; MASS SPECTROMETRY; PEPTIDE-N4-(N-ACETYL-BETA-GLUCOSAMINYL) ASPARAGINE AMIDASE; POLYETHYLENE GLYCOLS; REPRODUCIBILITY OF RESULTS; TRYPSIN;

EID: 33846560646     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2006.09.024     Document Type: Article

References (25)

1. Tang S., Nesta D.P., Maneri L.R., and Anumula K.R. J. Pharm. Biomed. Anal. 19 (1999) 569-583
2. Hunt G., Moorhouse K.G., and Chen A.B. J. Chromatogr. A 744 (1996) 295-301
3. Schriebl K., Trummer E., Weik R., Muller D., Kunert R., Lattenmayer C., Katinger H., and Vorauer Uhl K. J. Pharm. Biomed. Anal. 42 (2006) 322-327
4. Zhang W., and Czupryn M.J. J. Pharm. Biomed. Anal. 30 (2003) 1479-1490
5. Busnel J.M., Kilar F., Kasicka V., Descroix S., Hennion M.C., and Peltre G. J. Chromatogr. A 1087 (2005) 183-188
6. Tsai P.K., Bruner M.W., Irwin J.I., Yu Ip C.C., Oliver C.N., Nelson R.W., Volkin D.B., and Middaugh C.R. Pharm. Res. 10 (1993) 1580-1586
7. Bo T., and Pawliszyn J. J. Chromatogr. A 1105 (2006) 25-32
8. Moorhouse K.G., Eusebio C.A., Hunt G., and Chen A.B. J. Chromatogr. A 717 (1995) 61-69
9. L.C. Santosa, I.S. Krull, K.L. Grant, Using cIEF to Characterize Recombinant Human Monoclonal Antibodies, Beckman Coulter App. Note A-1861A.
10. Spanik I., Lim P., and Vigh G. J. Chromatogr. A 960 (2002) 241-246
11. Goodridge L., Goodridge C., Wu J., Griffiths M., and Pawliszyn J. Anal. Chem. 76 (2004) 48-52
12. Hjerten S., and Zhu M. J. Chromatgr. 346 (1985) 265-270
13. Hunt G., Hotaling T., and Chen A.B. J. Chromatogr. A 800 (1998) 355-367
14. Santora L.C., Krull I.S., and Grant K. Anal. Biochem. 275 (1999) 98-108
15. Harris R.J., Kabakoff B., Macchi F.D., Shen F.J., Kwong M., Andya J.D., Shire S.J., Bjork N., Totpal K., and Chen A.B. J. Chromatogr. B 752 (2001) 233-245
16. Harris R.J. J. Chromatogr. A 705 (1995) 129-134
17. Wright H.T. Protein Eng. 4 (1991) 283-294
18. Editorial, Mechanisms of Ageing and Development, 125 (2004) 255-257.
19. De Boni S., Oberthür C., Hamburger M., and Scriba G.K.E. J. Chromatogr. A 1022 (2004) 95-102
20. Mao Q., and Pawliszyn J. J. Biochem. Biophys. Meth. 39 (1999) 93-110
21. Conti M., Galassi M., Bossi A., and Righetti P.G. J. Chromatogr. A 757 (1997) 237-245
22. Furuya K., Karunatilake C., and Wang G.S.-X. 7th Symposium on the Practical Applications for the Analysis of Protein Nucleotides and Small Molecules. August 12-16 (2005)
23. Harris J.M., and Chess R.B. Nat. Rev. Drug Discov. 3 (2003) 214-221
24. L. Bass, Strategy for Evaluation of Analytical Comparability of PEGylated Biomolecules; at State of the Art Analytical Methods for the characterization of Biological Products and Assessment of Comparability, NIH, June 10th, 2003.
25. Lasdun A.M., Kurumbail R.R., Leimgruber N.K., and Rathore A.S. J. Chromatogr. A 917 (2001) 147-158