Site-Specific Characterization and Absolute Quantification of Pegfilgrastim Oxidation by Top-Down High-Performance Liquid Chromatography-Mass Spectrometry

Analytical Chemistry

Volumn 87, Issue 18, 2015, Pages 9336-9343

  Forstenlehner, Ines C ^a   Holzmann, Johann ^a,b   Toll, Hansjörg ^a,b   Huber, Christian G ^a  

^a UNIVERSITY OF SALZBURG   (Austria)

^b NOVARTIS PHARMA AG   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

ABSORPTION SPECTROSCOPY; BIOACTIVITY; CHROMATOGRAPHY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; IONS; MASS SPECTROMETRY; OXIDATION; POLYETHYLENE GLYCOLS; PROTEINS; SPECTROMETRY;

ABSOLUTE QUANTIFICATION; BIOPHARMACEUTICALS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY-MASS SPECTROMETRIES; LOWER LIMIT OF DETECTIONS; LOWER LIMIT OF QUANTIFICATIONS; RECOMBINANT HUMAN GRANULOCYTE COLONY STIMULATING FACTORS; RELATIVE STANDARD DEVIATIONS; UV ABSORPTION SPECTROSCOPY;

LIQUID CHROMATOGRAPHY;

DRUG; GRANULOCYTE COLONY STIMULATING FACTOR; MACROGOL DERIVATIVE; PEGFILGRASTIM; RECOMBINANT PROTEIN;

AMINO ACID SEQUENCE; BINDING SITE; CHEMISTRY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MOLECULAR GENETICS; MOLECULAR WEIGHT; OXIDATION REDUCTION REACTION; PROCEDURES;

AMINO ACID SEQUENCE; BINDING SITES; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; GRANULOCYTE COLONY-STIMULATING FACTOR; MASS SPECTROMETRY; MOLECULAR SEQUENCE DATA; MOLECULAR WEIGHT; OXIDATION-REDUCTION; PHARMACEUTICAL PREPARATIONS; POLYETHYLENE GLYCOLS; RECOMBINANT PROTEINS;

EID: 84941626475     PISSN: 00032700     EISSN: 15206882     Source Type: Journal    
DOI: 10.1021/acs.analchem.5b02029     Document Type: Article

References (36)

1. Holmes, F. A.; Jones, S. E.; O'Shaughnessy, J.; Vukelja, S.; George, T.; Savin, M.; Richards, D.; Glaspy, J.; Meza, L.; Cohen, G.; Dhami, M.; Budman, D. R.; Hackett, J.; Brassard, M.; Yang, B. B.; Liang, B. C. Ann. Oncol. 2002, 13, 903-909 10.1093/annonc/mdf130
2. Piedmonte, D. M.; Treuheit, M. J. Adv. Drug Delivery Rev. 2008, 60, 50-58 10.1016/j.addr.2007.04.017
3. Jevsevar, S.; Kunstelj, M.; Porekar, V. G. Biotechnol. J. 2010, 5, 113-128 10.1002/biot.200900218
4. Harris, J. M.; Chess, R. B. Nat. Rev. Drug Discovery 2003, 2, 214-221 10.1038/nrd1033
5. Huang, L. H.; Gough, P. C.; DeFelippis, M. R. Anal. Chem. 2009, 81, 567-577 10.1021/ac801711u
6. Schellekens, H. Nat. Rev. Drug Discovery 2002, 1, 457-462 10.1038/nrd818
7. Sharma, B. Biotechnol. Adv. 2007, 25, 310-317 10.1016/j.biotechadv.2007.01.005
8. Silva, M. M.; Lamarre, B.; Cerasoli, E.; Rakowska, P.; Hills, A.; Bailey, M. J.; Wheeler, J. X.; Burns, C. J.; Gaines-Das, R. E.; Jones, C.; Robinson, C. J. Biologicals 2008, 36, 383-392 10.1016/j.biologicals.2008.06.003
9. Skrlin, A.; Kosor Krnic, E.; Gosak, D.; Prester, B.; Mrsa, V.; Vuletic, M.; Runac, D. J. Pharm. Biomed. Anal. 2010, 53, 262-268 10.1016/j.jpba.2010.02.006
10. Gucinski, A. C.; Boyne, M. T., 2nd Anal. Chem. 2012, 84, 8045-8051 10.1021/ac301949j
11. Holzmann, J.; Hausberger, A.; Rupprechter, A.; Toll, H. Anal. Bioanal. Chem. 2013, 405, 6667-6674 10.1007/s00216-013-7138-0
12. Molineux, G. Curr. Pharm. Des. 2004, 10, 1235-1244 10.2174/1381612043452613
13. Lu, H. S.; Fausset, P. R.; Narhi, L. O.; Horan, T.; Shinagawa, K.; Shimamoto, G.; Boone, T. C. Arch. Biochem. Biophys. 1999, 362, 1-11 10.1006/abbi.1998.1022
14. Yin, J.; Chu, J. W.; Ricci, M. S.; Brems, D. N.; Wang, D. I.; Trout, B. L. Pharm. Res. 2005, 22, 141-147 10.1007/s11095-004-9019-x
15. Yin, J.; Chu, J. W.; Ricci, M. S.; Brems, D. N.; Wang, D. I.; Trout, B. L. Pharm. Res. 2004, 21, 2377-2383 10.1007/s11095-004-7692-4
16. Bagal, D.; Zhang, H.; Schnier, P. D. Anal. Chem. 2008, 80, 2408-2418 10.1021/ac7020163
17. Houde, D.; Kauppinen, P.; Mhatre, R.; Lyubarskaya, Y. J. Chromatogr. A 2006, 1123, 189-198 10.1016/j.chroma.2006.04.046
18. Griffiths, S. W.; Cooney, C. L. J. Chromatogr. A 2002, 942, 133-143 10.1016/S0021-9673(01)01350-4
19. Zang, L.; Carlage, T.; Murphy, D.; Frenkel, R.; Bryngelson, P.; Madsen, M.; Lyubarskaya, Y. J. Chromatogr. B: Anal. Technol. Biomed. Life Sci. 2012, 895-896, 71-76 10.1016/j.jchromb.2012.03.016
20. Sandra, K.; Vandenheede, I.; Sandra, P. J. Chromatogr. A 2014, 1335, 81-103 10.1016/j.chroma.2013.11.057
21. Heudi, O.; Barteau, S.; Zimmer, D.; Schmidt, J.; Bill, K.; Lehmann, N.; Bauer, C.; Kretz, O. Anal. Chem. 2008, 80, 4200-4207 10.1021/ac800205s
22. Ji, C.; Sadagopan, N.; Zhang, Y.; Lepsy, C. Anal. Chem. 2009, 81, 9321-9328 10.1021/ac901800f
23. Mayr, B. M.; Kohlbacher, O.; Reinert, K.; Sturm, M.; Gröpl, C.; Lange, E.; Klein, C.; Huber, C. G. J. Proteome Res. 2006, 5, 414-421 10.1021/pr050344u
24. Kirkpatrick, D. S.; Gerber, S. A.; Gygi, S. P. Methods 2005, 35, 265-273 10.1016/j.ymeth.2004.08.018
25. Yang, Z.; Ke, J.; Hayes, M.; Bryant, M.; Tse, F. L. J. Chromatogr. B: Anal. Technol. Biomed. Life Sci. 2009, 877, 1737-1742 10.1016/j.jchromb.2009.04.033
26. Wu, S. T.; Ouyang, Z.; Olah, T. V.; Jemal, M. Rapid Commun. Mass Spectrom. 2011, 25, 281-290 10.1002/rcm.4856
27. Du, Y.; Wang, F.; May, K.; Xu, W.; Liu, H. Anal. Chem. 2012, 84, 6355-6360 10.1021/ac3013362
28. Perdivara, I.; Deterding, L. J.; Przybylski, M.; Tomer, K. B. J. Am. Soc. Mass Spectrom. 2010, 21, 1114-1117 10.1016/j.jasms.2010.02.016
29. Li, H.; Rose, M. J.; Holder, J. R.; Wright, M.; Miranda, L. P.; James, C. A. J. Am. Soc. Mass Spectrom. 2011, 22, 1660-1667 10.1007/s13361-011-0180-2
30. Forstenlehner, I. C.; Holzmann, J.; Scheffler, K.; Wieder, W.; Toll, H.; Huber, C. G. Anal. Chem. 2014, 86, 826-834 10.1021/ac403390y
31. Ruan, Q.; Ji, Q. C.; Arnold, M. E.; Humphreys, W. G.; Zhu, M. Anal. Chem. 2011, 83, 8937-8944 10.1021/ac201540t
32. Huber, C. G.; Premstaller, A. J. Chromatogr. A 1999, 849, 161-173 10.1016/S0021-9673(99)00532-4
33. LeDuc, R. D.; Taylor, G. K.; Kim, Y. B.; Januszyk, T. E.; Bynum, L. H.; Sola, J. V.; Garavelli, J. S.; Kelleher, N. L. Nucleic Acids Res. 2004, 32, W340-345 10.1093/nar/gkh447
34. Ji, Q. C.; Rodila, R.; Gage, E. M.; El-Shourbagy, T. A. Anal. Chem. 2003, 75, 7008-7014 10.1021/ac034930n
35. Kalli, A.; Smith, G. T.; Sweredoski, M. J.; Hess, S. J. Proteome Res. 2013, 12, 3071-3086 10.1021/pr3011588
36. Bateman, K. P.; Kellmann, M.; Muenster, H.; Papp, R.; Taylor, L. J. Am. Soc. Mass Spectrom. 2009, 20, 1441-1450 10.1016/j.jasms.2009.03.002