Fully validated LC-MS/MS assay for the simultaneous quantitation of coadministered therapeutic antibodies in cynomolgus monkey serum

Analytical Chemistry

Volumn 85, Issue 20, 2013, Pages 9859-9867

  Jiang, Hao ^a   Zeng, Jianing ^a   Titsch, Craig ^a   Voronin, Kimberly ^b   Akinsanya, Billy ^a   Luo, Linlin ^a   Shen, Hongwu ^b   Desai, Dharmesh D ^a   Allentoff, Alban ^b   Aubry, Anne Françoise ^a   Desilva, Binodh S ^a   Arnold, Mark E ^a  

^a Analytical and Bioanalytical Development   (United States)

^b BRISTOL MYERS SQUIBB   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CYNOMOLGUS MONKEYS; DATA REPRODUCIBILITY; HUMAN MONOCLONAL ANTIBODIES; INTER-ASSAY PRECISION; ISOTOPICALLY LABELED; LOWER LIMIT OF QUANTITATIONS; THERAPEUTIC ANTIBODIES; VALIDATION PARAMETERS;

AMINO ACIDS; BODY FLUIDS; PEPTIDES; RECOVERY;

ANTIBODIES;

MONOCLONAL ANTIBODY; TRYPSIN;

ANIMAL; ARTICLE; BLOOD; BLOOD ANALYSIS; FEASIBILITY STUDY; HUMAN; LIQUID CHROMATOGRAPHY; MACACA FASCICULARIS; METABOLISM; METHODOLOGY; PRECIPITATION; PROTEIN DENATURATION; TANDEM MASS SPECTROMETRY; TIME; VALIDATION STUDY;

ANIMALS; ANTIBODIES, MONOCLONAL; BLOOD CHEMICAL ANALYSIS; CHEMICAL PRECIPITATION; CHROMATOGRAPHY, LIQUID; FEASIBILITY STUDIES; HUMANS; MACACA FASCICULARIS; PROTEIN DENATURATION; TANDEM MASS SPECTROMETRY; TIME FACTORS; TRYPSIN;

EID: 84886937152     PISSN: 00032700     EISSN: 15206882     Source Type: Journal    
DOI: 10.1021/ac402420v     Document Type: Article

References (30)

1. Scott, A. M.; Wolchok, J. D.; Old, L. J. Nat. Rev. Cancer 2012, 12, 278-287
2. Elvin, J. G.; Couston, R. G.; van der Walle, C. F. Int. J. Pharm. 2013, 440, 83-98
3. van den Broek, I.; Niessen, W. M. A.; van Dongen, W. D. J. Chromatogr., B. 2013, 929, 161-79
4. Tamvakopoulos, C. Mass Spectrom. Rev. 2007, 26, 389-402
5. van den Broek, I.; Sparidans, R. W.; Schellens, J. H. M.; Beijnen, J. H. J. Chromatogr., B 2008, 872, 1-22
6. Liu, H.; Manuilov, A. V.; Chumsae, C.; Babineau, M. L.; Tarcsa, E. Anal. Biochem. 2011, 414, 147-153
7. Hagman, C.; Ricke, D.; Ewert, S.; Bek, S.; Falchetto, R.; Bitsch, F. Anal. Chem. 2008, 80, 1290-1296
8. Ewles, M.; Goodwin, L. Bioanalysis 2011, 3, 1379-1397
9. Kirsch, S.; Widart, J.; Louette, J.; Focant, J. F.; De Pauw, E. J. Chromatogr., A. 2007, 1153, 300-306
10. Becher, F.; Pruvost, A.; Clement, G.; Tabet, J. C.; Ezan, E. Anal. Chem. 2006, 8, 2306-2313
11. Buscher, B. A. P.; Gerritsen, H.; van Schöll, I.; Cnubben, N. H. P.; Brüll, L. P. J. Chromatogr., B 2007, 852, 631-634
12. van Platerink, C. J.; Janssen, H. G.; Horsten, R.; Haverkamp, J. J. Chromatogr., B 2006, 830, 151-157
13. Wu, S. T.; Ouyang, Z.; Olah, T. V.; Jemal, M. Rapid Commun. Mass Spectrom. 2011, 25, 281-290
14. Berna, M. J.; Zhen, Y.; Watson, D. E.; Hale, J. E.; Ackermann, B. L. Anal. Chem. 2007, 79, 4199-4205
15. Wolf, R.; Hoffmann, T.; Rosche, F.; Demuth, H. U. J. Chromatogr., B 2004, 803, 91-99
16. Li, H.; Ortiz, R.; Tran, L.; Hall, M.; Spahr, C.; Walker, K.; Laudemann, J.; Miller, S.; Salimi-Moosavi, H.; Lee, J. W. Anal. Chem. 2012, 84, 1267-1273
17. Neubert, H.; Muirhead, D.; Kabir, M.; Grace, C.; Cleton, A.; Arends, R. Anal. Chem. 2013, 85, 1719-1726
18. Heinig, K.; Wirz, T. Anal. Chem. 2009, 81, 3705-3713
19. Kushnir, M. M.; Rockwood, A. L.; Roberts, W. L.; Abraham, D.; Hoofnagle, A. N.; Meikle, A. W. Clin. Chem. 2013, 59, 982-990
20. Ouyang, Z.; Furlong, M. T.; Wu, S.; Sleczka, B.; Tamura, J.; Wang, H.; Suchard, S.; Suri, A.; Olah, T.; Tymiak, A.; Jemal, M. Bioanalysis 2012, 4, 17-28
21. Liu, G.; Ji, Q. C.; Dodge, R.; Sun, H.; Shuster, D.; Zhao, Q.; Arnold, M. J. Chromatogr., A 2013, 1284, 155-162
22. Yuan, L.; Arnold, M. E.; Aubry, A. F.; Ji, Q. C. Bioanalysis 2012, 4, 2887-2896
23. Guidance for Industry: Bioanalytical Method Validation. Food and Drug Administration, 2001. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm070107.pdf (accessed Mar 21, 2013).
24. Guideline on bioanalytical method validation. European medicines agency, 2011. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/ 2011/08/WC500109686.pdf (accessed Mar 21, 2013).
25. Babu, K. R.; Douglas, D. J. Biochemistry 2000, 39, 14702-14710
26. Babu, K. R.; Moradian, A.; Douglas, D. J. J. Am. Soc. Mass Spectrom. 2001, 12, 317-328
27. Furlong, M. T.; Ouyang, Z.; Wu, S.; Tamura, J.; Olah, T.; Tymiak, A.; Jemal, M. Biomed. Chromatogr. 2012, 26, 1024-1032
28. Vogt, W. Free Radic. Biol. Med. 1995, 18, 93-105
29. Schöneich, C. Biochim. Biophys. Acta 2005, 1703, 111-119
30. Stadtman, E. R.; Van Remmen, H.; Richardson, A.; Wehr, N. B.; Levine, R. L. Biochim. Biophys. Acta 2005, 1703, 135-140